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MEDICAL products beginning with : F
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 PRODUCT NAMEFDA Code/Regulation 
Frontal-Sinus Rasp (17 suppliers)KAZ / 874.4420
Frozen Blood Processor (3 suppliers)

Identification. A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion.

Classification. Class II (performance standards).

KSW / 864.9145
Frozen Donor Tissue Storage Container (8 suppliers)LPZ
Fructose-1, 6-Diphosphate and NADH (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.

CJC / 862.1040
FTA-ABS Test Anti-Human Globulin (5 suppliers)GMS / 866.3830
FTA-ABS Test Reactive and Non-Specific Control Serum (2 suppliers)GMR / 866.3830
FTA-ABS Test Sorbent (2 suppliers)GMW / 866.3830
Functional Neuromuscular Scoliosis Stimulator (2 suppliers)LWB
Functional Optical Coherence Tomography (8 suppliers)
Functional optical coherence tomography is an imaging technique that is applied in a wide range of medical and biological fields. It is a non-contact, noninvasive imaging technique mainly used to obtain high resolution cross-sectional images of the retina. It is suitable for detecting optical scattering changes in individual nerve fibers during electrical activity. It is well suited for detecting neural activity in tissue because it provides noninvasive monitoring, high imaging resolution, fast acquisition rates, and high sensitivity to small optical changes.

Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Classification. Class II.

OBO / 886.1570
Fusion and Stereoscopic Target (8 suppliers)

Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (886.1870).

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.

HLP / 886.1880
Fusion Posterior Metal/Polymer Spinal System (8 suppliers)

Identification. Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:

NQP / 888.3070
Flap Manipulator (1 supplier)
Flexible Position Sensors (1 supplier)
First Aid Adhesive Plaster (2 suppliers)
Frame Based Stereotactactic Systems (1 supplier)
Frame Based Stereotaxy Systems (1 supplier)
Foot Drop System (1 supplier)
Film Based X-Ray Machine (1 supplier)
Flat Lancet (1 supplier)
Filp Lens (0 suppliers)
Fistula Probe (5 suppliers)
Flexible Endoscopic Grasping Forceps (10 suppliers)
Flexible Gastroscope (8 suppliers)
Flexible Nephroscope (2 suppliers)
Faeces Container (1 supplier)
Filter Aspirators (2 suppliers)
False Bottom Analyzer Tube (1 supplier)
Fecal Specimen Collection Kits (1 supplier)
Fluidproof Gowns (1 supplier)
Foam Well-Leg Holder (1 supplier)
Frogger Pad (2 suppliers)
Flexible Anesthesia Screen (1 supplier)
Foot Section Gel Pad (2 suppliers)
Full Length Table Gel Pad (1 supplier)
Foot-Heel Gel Pad (2 suppliers)
Flex Frame Armboard Rail (1 supplier)
Flex Frame Short Accessory Rail (2 suppliers)
Flex Frame Long Accessory Rail (1 supplier)
Foam Reusable Positioners (1 supplier)
Foot & Ankle Gel Pads (1 supplier)
Friction Head Screw Systems (1 supplier)
Facet Bolts (1 supplier)
Flexible Rod Systems (1 supplier)
Fixed Handles without Adapters (1 supplier)
Fracture Orthoses (1 supplier)
Functional Knee Orthosis (1 supplier)
Femtosecond Laser Systems (1 supplier)
Flow Cytometer Analyzers (1 supplier)
Foam Biopsy Pads (1 supplier)
Finger Incision Devices (1 supplier)
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