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MEDICAL products beginning with : E
301 to 350 of 2376 results  Page: << Previous 50 Results 1 2 3 4 5 6 [7] 8 9 10 11 12 13 14 15 16 17 18 19 20 >> Next 50 Results
 PRODUCT NAMEFDA Code/Regulation 
External Inflatable Extremity Splint (35 suppliers)

Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

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.

FZF / 878.3900
External Knee/Shank/Ankle/Foot Assembly (11 suppliers)

Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

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.

ISW / 890.3500
External Limb Component Hip Joint (11 suppliers)

Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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 890.9. The device 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ISL / 890.3420
External Limb Component Knee Joint (29 suppliers)

Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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 890.9. The device 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ISY / 890.3420
External Limb Component Shoulder Joint (16 suppliers)

Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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 890.9. The device 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, regarding general requirements concerning records and 820.198, regarding complaint files.

IQQ / 890.3420
External Limb Component, Ankle/Foot (51 suppliers)

Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

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 890.9. The device 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, regarding general requirements concerning records and 820.198, regarding complaint files.

ISH / 890.3420
External Non-Inflatable Extremity Splint (64 suppliers)

Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

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 878.9. If the device is not labeled or otherwise represented as sterile, it is 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 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

FYH / 878.3910
External Pacemaker Pulse Generator (17 suppliers)

Identification. An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing sytem until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

Classification. Class III (premarket approval).

DTE / 870.3600
External Pelvimeter (26 suppliers)

Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 884.9.

HER / 884.4520
External Penile Rigidity Device (31 suppliers)LKY / 876.5020
External Programmable Pacemaker Pulse Generator (9 suppliers)

Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.

Classification. Class II (performance standards).

JOQ / 870.1750
External Prosthesis Adhesive (10 suppliers)

Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

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.

GBJ / 878.3750
External Thigh/Knee/Shank/Ankle/Foot Assembly (7 suppliers)

Identification. An external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.

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.

KFX / 890.3500
External Uterine Contraction Monitor (4 suppliers)

Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

Classification. Class II (performance standards).

HFM / 884.2720
External Vein Stripper (7 suppliers)

Identification. An external vein stripper is an extravascular device used to remove a section of a vein.

Classification. Class II (performance standards).

DWQ / 870.4885
Extra-Luminal Blood Pump (3 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.

FIR / 876.5820
Extra-Luminal Infusion/Syringe Pump (1 supplier)

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.

FIH / 876.5820
Extra-Ocular Orbital Implant (7 suppliers)

Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

Classification. Class II.

HQX / 886.3340
Extracorporeal Blood System and Accessories (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.

LLB / 876.5820
Extracorporeal Photopheresis System (2 suppliers)LNR
Extracorporeal System Accessories (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.

KXM / 876.5820
Extravascular Blood Flow Probe (11 suppliers)

Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Classification. Class II (performance standards).

DPT / 870.2120
Extravascular Blood Pressure Transducer (30 suppliers)

Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Classification. Class II (performance standards).

DRS / 870.2850
Extremity Lymphedema Extracellular Fluid Monitor (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).

OBH / 870.2770
Extremity Topical Oxygen Chamber (9 suppliers)

Identification. A topical oxygen chamber for extremities is a device intended to surround hermetically a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers or bed sores.

Classification. Class III.

KPJ / 878.5650
Eye Cup (6 suppliers)LXQ
Eye Knife Test Drum (6 suppliers)

Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.

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 886.9. The device 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.

HMS / 886.4230
Eye Movement Monitor (10 suppliers)

Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

Classification. Class II.

HLL / 886.1510
Eye Sphere Implant (14 suppliers)

Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Classification. Class II.

HPZ / 886.3320
Eye Tray (2 suppliers)

Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

Classification. Class II.

OJK / 886.4790
Eye Valve Implant (8 suppliers)

Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

Classification. Class II. The special controls for this device are FDA's:

KYF / 886.3920
Eyeglasses (80 suppliers)
Eyelid Prosthesis (1 supplier)
Elbow Immobilizer (11 suppliers)
Extra-Cranial Fixation Device (5 suppliers)
Ear Microscope (6 suppliers)
Ear Perforator (4 suppliers)
Ear Valve (1 supplier)
Eye Protective Goggles (41 suppliers)
Eye Dropper (9 suppliers)
Eye Irrigation Kit (6 suppliers)
Eye Bank Freezer (1 supplier)
Extended-Wear Contact Lens (6 suppliers)
Enucleator (1 supplier)
ENT Tuning Fork (12 suppliers)
ENT Lavage Unit (1 supplier)
ENT Nystagmograph (1 supplier)
ENT Tracheostomy Tube (8 suppliers)
ENT Atomizer and Tip (3 suppliers)
ENT Bite Block (3 suppliers)
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