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MEDICAL products beginning with : A
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 PRODUCT NAMEFDA Code/Regulation 
Adjustable Hospital AC-Powered Beds (147 suppliers)

Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

FNL / 880.5100
Adjustable Hospital Hydraulic Bed (31 suppliers)

Identification. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9.

FNK / 880.5110
Adjustable Operating Room Stool (48 suppliers)

Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

FZM / 878.4950
Adminstration Set Docking Station (2 suppliers)

Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in 880.9.

ODI / 880.5440
Adsorbent Liquid Chromatography (1 supplier)

Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

DMZ / 862.2260
Adult External Negative Pressure Body Ventilator/Cuirass (5 suppliers)

Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

Classification. Class II (performance standards).

BYT / 868.5935
Adult Tongue Depressor (166 suppliers)

Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

FMA / 880.6230
Aerobic Transport System (8 suppliers)

Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Classification. Class I (general controls).

JTW / 866.2900
Aerosol Adhesive Drape (17 suppliers)

Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.

KGT / 878.4380
Aesthetic Dermal Implant (12 suppliers)LMH
Aesthetic Purposes Transcutaneous Electrical Stimulator (5 suppliers)

Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Classification. Class II (performance standards).

NFO / 882.5890
Air Bubble Detectors (7 suppliers)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

FJF / 876.5820
Air Bubble Monitor (6 suppliers)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

FJF / 876.5820
Air Conduction Hearing Aid (209 suppliers)

Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400).

Classification. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.

ESD / 874.3300
Air Conduction Hearing Aid Transcutaneous System (1 supplier)

Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal.

Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA." See 874.1 for the availability of this guidance document.

NIX / 874.3950
Air Displacement For Body Composition Analysis Plethysmograph (1 supplier)

Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Classification. Class II (performance standards).

OAC / 870.2770
Air Flotation Mattress (98 suppliers)

Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

FNM / 880.5550
Air Fluidized Bed (10 suppliers)

Identification. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 890.9.

INX / 890.5160
Air Handling Apparatus (1 supplier)

Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Classification. Class II.

FZG / 878.5070
Air Or Foam Detector (2 suppliers)

Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.

KQR / 876.5820
Airway Pressure Monitor (24 suppliers)

Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Classification. Class II (performance standards).

CAP / 868.2600
Airway Pressure Monitor with Alarm (23 suppliers)

Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Classification. Class II (performance standards).

CAP / 868.2600
Airway Pressure Monitor with Gauge (23 suppliers)

Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Classification. Class II (performance standards).

CAP / 868.2600
Airway Suction Kit (1 supplier)

Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 868.9.

OFO / 868.6810
Albumin Antigen Antiserum Control (29 suppliers)

Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

DCF / 866.5040
Albumin Based Adhesive (6 suppliers)KEL / 864.4010
Albumin Cobalt Binding Test (1 supplier)

Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Classification. Class II.

NJV / 862.1215
Albumin Radial Immunodiffusion Test (2 suppliers)

Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Classification. Class II.

CJQ / 862.1035
Albumin Tetrabromo-M-Cresolsulfonphthalein Test (2 suppliers)

Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Classification. Class II.

CJG / 862.1035
Albumin, FITC Conjugate (14 suppliers)

Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

DDZ / 866.5040
Alcian Blue Stain (12 suppliers)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

IDA / 864.1850
Alcohol Breath Trapping Device (26 suppliers)

Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Classification. Class I.

DJZ / 862.3050
Alcohol Containing Fixative (31 suppliers)LDZ / 864.4010
Alcohol Control Materials (5 suppliers)

Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Classification. Class I (general controls). Except when used in donor screening, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

DKC / 862.3280
Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method (14 suppliers)

Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Classification. Class II.

DIC / 862.3040
Alcohol Pad (32 suppliers)LKB
Alcohol Potassium Dichromate Test (1 supplier)

Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Classification. Class II.

DOJ / 862.3040
Aldehyde Fuchsin Stain (6 suppliers)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

IDB / 864.1850
Aldolase Hydrazone Colorimetry Test (1 supplier)

Identification. An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

CJT / 862.1040
Aldosterone Chromatographic Separation/Radioimmunoassay Test (2 suppliers)

Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

Classification. Class II.

CJB / 862.1045
Aldosterone Radioimmunoassay Test (10 suppliers)

Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

Classification. Class II.

CJM / 862.1045
Alizarin Red Stain (5 suppliers)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

IDD / 864.1850
Alkali Resistant Hemoglobin (1 supplier)

Identification. A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

Classification. Class II (performance standards).

GHA / 864.7455
Alkaline Phosphatase (ALP) (16 suppliers)
Alkaline phosphatase is a protein found in all body tissues. Tissues with particularly high amounts of ALP include the liver, bile ducts, and bone. A blood test can be done to measure the level of ALP. This test is done to diagnose liver or bone disease, or to check if treatments for those diseases are working. It may be included as part of a routine liver function test.

Identification. A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.

JCJ / 864.7660
Alkaline Phosphatase Isoenzymes Electrophoretic Separation Test (14 suppliers)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

CIN / 862.1050
Alkaline Phosphatase, Phenolphthalein Phosphate Test (5 suppliers)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

CJK / 862.1050
Alkaline Phosphatase, Phenylphosphate Test (5 suppliers)

Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Classification. Class II.

CKF / 862.1050
Alkaline Picrate Creatinine Colorimetric Method (42 suppliers)

Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Classification. Class II.

CGX / 862.1225
Allergen and Vaccine Delivery System (21 suppliers)LDH
Alpha Fetoprotein L3 Subfraction (Afp-L3%) Test For Hepatocellular Carcinoma Risk Assessment (3 suppliers)NSF / 866.6030
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