Source: https://www.medicregister.com/Companies/AName/aidU.htm
Timestamp: 2018-07-17 23:48:54
Document Index: 616090082

Matched Legal Cases: ['art 807', 'art 820', 'art 807', 'art 820', 'art 807', 'art 820']

U.V Fluorescence Microscope,U.V Light Suppliers & Manufacturers
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U.V Fluorescence Microscope (17 suppliers)
Identification. Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:
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. 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
IBK / 864.3600
U.V Light (5 suppliers)
Identification. A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.
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. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are 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.
DJS / 862.2270
U.V. Method, CPK/Isoenzymes (12 suppliers)
JHW / 862.1215
U.V. Spectrometry Test for Theophylline (2 suppliers)
LCY / 862.3880
Ulnar Hemi- Wrist Prosthesis (6 suppliers)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.
KXE / 888.3810
Ultra Microtome (4 suppliers)
IDM / 864.3010
Ultrasonic Aspirator (8 suppliers)
An ultrasonic aspirator utilizes high-frequency vibrations to shatter tumor cells with sound waves before suctioning the debris away. The technique inflicts minimal damage on surrounding normal structures and blood vessels and is especially effective in firm tumors such as meningiomas and acoustic neuromas.
Ultrasonic Blood Flow Monitor (12 suppliers)
HEP / 884.2660
Ultrasonic Body Composition Analyzer (2 suppliers)
OMV / 870.2770
Ultrasonic Cleaners for Lenses (16 suppliers)
LYL / 886.5928
Ultrasonic Diathermy for use in Applying Therapeutic Deep Heat (34 suppliers)
Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
IMI / 890.5300
Ultrasonic Fetal Arterial Pressure Monitor (1 supplier)
HEQ / 884.2660
Ultrasonic Fetal Heart Rate Monitor (8 suppliers)
HEL / 884.2660
Ultrasonic Fetal Heart Sound Monitor (6 suppliers)
HEK / 884.2660
Ultrasonic Fetal Monitor (44 suppliers)
KNG / 884.2660
Ultrasonic Intracorporeal Device Locator (2 suppliers)
HHJ / 884.2225
Ultrasonic Lithotriptor (8 suppliers) FEO / 876.4480
Ultrasonic Obstetric-Gynecologic Imager (13 suppliers)
HEM / 884.2225
Ultrasonic Puls-Echo Scanner (151 suppliers)
IYO / 892.1560
Ultrasonic Pulsed Doppler Imaging System (98 suppliers)
IYN / 892.1550
Ultrasonic Scanner Calibration Test Block (2 suppliers)
GXX / 882.1925
Ultrasonic Surgical Instrument (26 suppliers) LFL
Ultrasonic Thermal Ablation Device (3 suppliers) MIK
Ultrasonic Transducer (26 suppliers)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.
JOP / 870.2880
Ultrasound Ablation System And Accessories (2 suppliers)
NTB / 878.4400
Ultrasound and Muscle Stimulator (2 suppliers) LPQ
Ultrasound Contrast Media (22 suppliers)
Ultrasound contrast media is a substance that enhances the information contained in an image produced by medical diagnostic equipments used in ultrasounds. It is available as solutions containing air or gas micro-bubbles that can efficiently reflect the ultrasound beams used during the investigation.
Ultrasound Coupling Media (9 suppliers)
MUI / 892.1570
Ultrasound Wound Cleaner (5 suppliers) NRB / 878.4410
Ultraviolet Alcohol Dehydrogenase Enzymatic Method (4 suppliers)
DMT / 862.3040
Ultraviolet Germicidal Device (1 supplier)
MKB / 880.6500
Umbilical Artery Catheter (36 suppliers)
An umbilical artery catheter is a small flexible tube that is put into the artery of the umbilical cord stump.
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
FOS / 880.5200
Umbilical Clamp (30 suppliers)
HFW / 884.4530
Umbilical Clamp And Cutter (3 suppliers)
NBZ / 884.4530
Umbilical Occlusion Device (36 suppliers)
FOD / 880.5950
Umbilical Scissors (85 suppliers)
HDJ / 884.4520
Umbilical Truss (9 suppliers)
Identification. A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.
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 876.9. 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.
EXM / 876.5970
Uncalibrated Breathing System Collection Bottle (8 suppliers)
CBC / 880.6740
Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (41 suppliers)
LWJ / 888.3360
Uncemented Metal/Polymer Shoulder Prosthesis (9 suppliers)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.
Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis."
MBF / 888.3670
Uncemented Patellar Resurfacing Hemi- Knee Prosthesis (3 suppliers)
Identification. A knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace the retropatellar articular surface of the patellofemoral joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a retropatellar resurfacing component and an orthopedic screw to transfix the patellar remnant. This generic type of device is limited to those prostheses intended for use without bone cement (888.3027).
Classification. (1) Class II when intended for treatment of degenerative and posttraumatic patellar arthritis.
HTG / 888.3580
Uncemented Porous + Additive Metal/Polymer Cemented Semi-Constrained Hip Prosthesis (1 supplier)
OQG / 888.3358
Uncemented Semi-Constrained Patellofemorotibial Knee Prosthesis (2 suppliers)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
MBV / 888.3560
Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (33 suppliers)
LZO / 888.3353
Uncompensated Thorpe Tube (4 suppliers)
BYM / 868.2320
Unipolar Endoscopic Coagulator-cutter and Accessories (27 suppliers)
KNF / 884.4160
Unipolar Laparoscopic Coagulator (17 suppliers)
HFG / 884.4160
Unpowered Dialysis Chair (8 suppliers)
FIA / 876.5820
Unscented Menstrual Pad (105 suppliers)
HHD / 884.5435
Unscented Menstrual Tampon (37 suppliers)
HEB / 884.5470