| This page provides information on persons
accredited (as of the above date of revision) to review selected premarket notifications
[510(k)s] and the devices they may review. Information on this list will be updated
within 10 working days after the date reflected on the third party's accreditation
letter. Each classified device type on the list of devices eligible for Third Party
Review has one or more product codes associated with it. Devices eligible for review
by Third Parties are limited to the product codes shown on the list of eligible
devices. Please refer to the List of Devices for Third Party Review Under the FDA
Modernization Act (FDAMA) of 1997 to assure your device is eligible for the Accredited
Person Program. To-date, FDA has not withdrawn accreditation from any Accredited Person. |
|
|
|
|
|
|
|
|
|
|
|
|
|
THIRD PARTY REVIEW GROUP, LLC
|
|
|
|
|
| THIRD PARTY REVIEW GROUP, LLC |
|
|
|
|
| Panel | Section Number | Regulation Name / Device Name | Class |
| Anesthesiology |
| |
868.1040 |
Powered algesimeter. |
II |
| |
868.1075 |
Argon gas analyzer. |
II |
| |
868.1150 |
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer. |
II |
| |
868.1170 |
Indwelling blood hydrogen ion concentration (pH) analyzer. |
II |
| |
868.1200 |
Indwelling blood oxygen partial pressure (PO2) analyzer. |
II |
| |
868.1400 |
Carbon dioxide gas analyzer. |
II |
| |
868.1430 |
Carbon monoxide gas analyzer. |
II |
| |
868.1500 |
Enflurane gas analyzer. |
II |
| |
868.1620 |
Halothane gas analyzer. |
II |
| |
868.1640 |
Helium gas analyzer. |
II |
| |
868.1670 |
Neon gas analyzer. |
II |
| |
868.1690 |
Nitrogen gas analyzer. |
II |
| |
868.1700 |
Nitrous oxide gas analyzer. |
II |
| |
868.1720 |
Oxygen gas analyzer. |
II |
| |
868.1730 |
Oxygen uptake computer. |
II |
| |
868.1750 |
Pressure plethysmograph. |
II |
| |
868.1760 |
Volume plethysmograph. |
II |
| |
868.1780 |
Inspiratory airway pressure meter. |
II |
| |
868.1800 |
Rhinoanemometer. |
II |
| |
868.1840 |
Diagnostic spirometer. |
II |
| |
868.1850 |
Monitoring spirometer. |
II |
| |
868.1860 |
Peak-flow meter for spirometry. |
II |
| |
868.1880 |
Pulmonary-function data calculator. |
II |
| |
868.1890 |
Predictive pulmonary-function value calculator. |
II |
| |
868.1900 |
Diagnostic pulmonary-function interpretation calculator. |
II |
| |
868.1920 |
Esophageal stethoscope with electrical conductors. |
II |
| |
868.2025 |
Ultrasonic air embolism monitor. |
II |
| |
868.2375 |
Breathing frequency monitor. |
II |
| |
868.2385 |
Nitrogen dioxide analyzer. |
II |
| |
868.2500 |
Cutaneous oxygen (PcO2) monitor. |
II |
| |
868.2550 |
Pneumotachometer. |
II |
| |
868.2600 |
Airway pressure monitor. |
II |
| |
868.2775 |
Electrical peripheral nerve stimulator. |
II |
| |
868.5090 |
Emergency airway needle. |
II |
| |
868.5120 |
Anesthesia conduction catheter. |
II |
| |
868.5130 |
Anesthesia conduction filter. |
II |
| |
868.5140 |
Anesthesia conduction kit. |
II |
| |
868.5150 |
Anesthesia conduction needle. |
II |
| |
868.5170 |
Laryngotracheal topical anesthesia applicator. |
II |
| |
868.5180 |
Rocking bed. |
II |
| |
868.5250 |
Breathing circuit circulator. |
II |
| |
868.5260 |
Breathing circuit bacterial filter. |
II |
| |
868.5270 |
Breathing system heater. |
II |
| |
868.5330 |
Breathing gas mixer. |
II |
| |
868.5430 |
Gas-scavenging apparatus. |
II |
| |
868.5440 |
Portable oxygen generator. |
II |
| |
868.5450 |
Respiratory gas humidifier. |
II |
| |
868.5470 |
Hyperbaric chamber. |
II |
| |
868.5630 |
Nebulizer. |
II |
| |
868.5655 |
Portable liquid oxygen unit. |
II |
| |
868.5665 |
Powered percussor. |
II |
| |
868.5690 |
Incentive spirometer. |
II |
| |
868.5710 |
Electrically powered oxygen tent. |
II |
| |
868.5730 |
Tracheal tube. |
II |
| |
868.5750 |
Inflatable tracheal tube cuff. |
II |
| |
868.5800 |
Tracheostomy tube and tube cuff. |
II |
| |
868.5870 |
Nonrebreathing valve. |
II |
| |
868.5880 |
Anesthetic vaporizer. |
II |
| |
868.5895 |
Continuous ventilator. |
II |
| |
868.5905 |
Noncontinuous ventilator (IPPB). |
II |
| |
868.5915 |
Manual emergency ventilator. |
II |
| |
868.5925 |
Powered emergency ventilator. |
II |
| |
868.5965 |
Positive end expiratory pressure breathing attachment. |
II |
| |
868.6250 |
Portable air compressor. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
| |
862.1410 |
Iron (non-heme) test system. |
I |
| |
862.1415 |
Iron-binding capacity test system. |
I |
| |
862.1495 |
Magnesium test system. |
I |
| |
862.1580 |
Phosphorus (inorganic) test system. |
I |
| |
862.1660 |
Quality control material (assayed and unassayed). |
I |
| |
862.1680 |
Testosterone test system. |
I |
| |
862.1775 |
Uric acid test system. |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Cardiovascular |
| |
870.1100 |
Blood pressure alarm. |
II |
| |
870.1110 |
Blood pressure computer. |
II |
| |
870.1120 |
Blood pressure cuff. |
II |
| |
870.1130 |
Noninvasive blood pressure measurement system. |
II |
| |
870.1140 |
Venous blood pressure manometer. |
II |
| |
870.1200 |
Diagnostic intravascular catheter. |
II |
| |
870.1210 |
Continuous flush catheter. |
II |
| |
870.1230 |
Fiberoptic oximeter catheter. |
II |
| |
870.1240 |
Flow-directed catheter. |
II |
| |
870.1250 |
Percutaneous catheter. |
II |
| |
870.1270 |
Intracavitary phonocatheter system. |
II |
| |
870.1280 |
Steerable catheter. |
II |
| |
870.1290 |
Steerable catheter control system. |
II |
| |
870.1300 |
Catheter cannula. |
II |
| |
870.1310 |
Vessel dilator for percutaneous catheterization. |
II |
| |
870.1330 |
Catheter guide wire. |
II |
| |
870.1340 |
Catheter introducer. |
II |
| |
870.1370 |
Catheter tip occluder. |
II |
| |
870.1380 |
Catheter stylet. |
II |
| |
870.1390 |
Trocar. |
II |
| |
870.1425 |
Programmable diagnostic computer. |
II |
| |
870.1435 |
Single-function, preprogrammed diagnostic computer. |
II |
| |
870.1450 |
Densitometer. |
II |
| |
870.1650 |
Angiographic injector and syringe. |
II |
| |
870.1660 |
Indicator injector. |
II |
| |
870.1670 |
Syringe actuator for an injector. |
II |
| |
870.1800 |
Withdrawal-infusion pump. |
II |
| |
870.1875 |
Stethoscope. |
II |
| |
870.1915 |
Thermodilution probe. |
II |
| |
870.2050 |
Biopotential amplifier and signal conditioner. |
II |
| |
870.2060 |
Transducer signal amplifier and conditioner. |
II |
| |
870.2100 |
Cardiovascular blood flowmeter. |
II |
| |
870.2120 |
Extravascular blood flow probe. |
II |
| |
870.2300 |
Cardiac monitor (including cardiotachometer and rate alarm). |
II |
| |
870.2310 |
Apex cardiograph (vibrocardiograph). |
II |
| |
870.2320 |
Ballistocardiograph. |
II |
| |
870.2330 |
Echocardiograph. |
II |
| |
870.2340 |
Electrocardiograph. |
II |
| |
870.2350 |
Electrocardiograph lead switching adaptor. |
II |
| |
870.2360 |
Electrocardiograph electrode. |
II |
| |
870.2370 |
Electrocardiograph surface electrode tester. |
II |
| |
870.2400 |
Vectorcardiograph. |
II |
| |
870.2450 |
Medical cathode-ray tube display. |
II |
| |
870.2675 |
Oscillometer. |
II |
| |
870.2750 |
Impedance phlebograph. |
II |
| |
870.2770 |
Impedance plethysmograph. |
II |
| |
870.2780 |
Hydraulic, pneumatic, or photoelectric plethysmographs. |
II |
| |
870.2800 |
Medical magnetic tape recorder. |
II |
| |
870.2840 |
Apex cardiographic transducer. |
II |
| |
870.2850 |
Extravascular blood pressure transducer. |
II |
| |
870.2860 |
Heart sound transducer. |
II |
| |
870.2870 |
Catheter tip pressure transducer. |
II |
| |
870.2880 |
Ultrasonic transducer. |
II |
| |
870.2890 |
Vessel occlusion transducer. |
II |
| |
870.2900 |
Patient transducer and electrode cable (including connector). |
II |
| |
870.2910 |
Radiofrequency physiological signal transmitter and receiver. |
II |
| |
870.2920 |
Telephone electrocardiograph transmitter and receiver. |
II |
| |
870.3630 |
Pacemaker generator function analyzer. |
II |
| |
870.3640 |
Indirect pacemaker generator function analyzer. |
II |
| |
870.3720 |
Pacemaker electrode function tester. |
II |
| |
870.4075 |
Endomyocardial biopsy device. |
II |
| |
870.4205 |
Cardiopulmonary bypass bubble detector. |
II |
| |
870.4210 |
Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
II |
| |
870.4270 |
Cardiopulmonary bypass cardiotomy suction line blood filter. |
II |
| |
870.4280 |
Cardiopulmonary prebypass filter. |
II |
| |
870.4290 |
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. |
II |
| |
870.4310 |
Cardiopulmonary bypass coronary pressure gauge. |
II |
| |
870.4330 |
Cardiopulmonary bypass on-line blood gas monitor. |
II |
| |
870.4340 |
Cardiopulmonary bypass level sensing monitor and/or control. |
II |
| |
870.4390 |
Cardiopulmonary bypass pump tubing. |
II |
| |
870.4400 |
Cardiopulmonary bypass blood reservoir. |
II |
| |
870.4410 |
Cardiopulmonary bypass in-line blood gas sensor. |
II |
| |
870.4420 |
Cardiopulmonary bypass cardiotomy return sucker. |
II |
| |
870.4430 |
Cardiopulmonary bypass intracardiac suction control. |
II |
| |
870.4450 |
Vascular clamp. |
II |
| |
870.4475 |
Surgical vessel dilator. |
II |
| |
870.4875 |
Intraluminal artery stripper. |
II |
| |
870.4885 |
External vein stripper. |
II |
| |
870.5050 |
Patient care suction apparatus. |
II |
| |
870.5150 |
Embolectomy catheter. |
II |
| |
870.5175 |
Septostomy catheter. |
II |
| |
870.5325 |
Defibrillator tester. |
II |
| |
870.5800 |
Compressible limb sleeve. |
II |
| |
870.5900 |
Thermal regulating system. |
II |
| |
870.5925 |
Automatic rotating tourniquet. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Dental |
| |
872.1720 |
Pulp tester. |
II |
| |
872.1740 |
Caries detection device. |
II |
| |
872.1800 |
Extraoral source x-ray system. |
II |
| |
872.1810 |
Intraoral source x-ray system. |
II |
| |
872.1830 |
Cephalometer. |
II |
| |
872.1870 |
Sulfide detection device. |
II |
| |
872.3060 |
Noble metal alloy. |
II |
| |
872.3070 |
Dental amalgam, mercury, and amalgam alloy. |
II |
| |
872.3200 |
Resin tooth bonding agent. |
II |
| |
872.3250 |
Calcium hydroxide cavity liner. |
II |
| |
872.3260 |
Cavity varnish. |
II |
| |
872.3275 |
Dental cement. |
II |
| |
872.3300 |
Hydrophilic resin coating for dentures. |
II |
| |
872.3310 |
Coating material for resin fillings. |
II |
| |
872.3520 |
OTC denture cleanser. |
I |
| |
872.3540 |
OTC denture cushion or pad. |
II |
| |
872.3560 |
OTC denture reliner. |
II |
| |
872.3570 |
OTC denture repair kit. |
II |
| |
872.3590 |
Preformed plastic denture tooth. |
II |
| |
872.3600 |
Partially fabricated denture kit. |
II |
| |
872.3660 |
Impression material. |
II |
| |
872.3690 |
Tooth shade resin material. |
II |
| |
872.3710 |
Base metal alloy. |
II |
| |
872.3750 |
Bracket adhesive resin and tooth conditioner. |
II |
| |
872.3760 |
Denture relining, repairing, or rebasing resin. |
II |
| |
872.3765 |
Pit and fissure sealant and conditioner. |
II |
| |
872.3770 |
Temporary crown and bridge resin. |
II |
| |
872.3820 |
Root canal filling resin. |
II |
| |
872.3890 |
Endodontic stabilizing splint. |
II |
| |
872.3920 |
Porcelain tooth. |
II |
| |
872.4120 |
Bone cutting instrument and accessories. |
II |
| |
872.4200 |
Dental handpiece and accessories. |
I |
| |
872.4465 |
Gas-powered jet injector. |
II |
| |
872.4475 |
Spring-powered jet injector. |
II |
| |
872.4565 |
Dental hand instrument. |
I |
| |
872.4840 |
Rotary scaler. |
II |
| |
872.4850 |
Ultrasonic scaler. |
II |
| |
872.4920 |
Dental electrosurgical unit and accessories. |
II |
| |
872.5470 |
Orthodontic plastic bracket. |
II |
| |
872.5500 |
Extraoral orthodontic headgear. |
II |
| |
872.5550 |
Teething ring. |
II |
| |
872.5570 |
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
II |
| |
872.6070 |
Ultraviolet activator for polymerization. |
II |
| |
872.6080 |
Airbrush. |
II |
| |
872.6250 |
Dental chair and accessories. |
I |
| |
872.6350 |
Ultraviolet detector. |
II |
| |
872.6640 |
Dental operative unit and accessories. |
I |
| |
872.6660 |
Porcelain powder for clinical use. |
II |
| |
872.6710 |
Boiling water sterilizer. |
I |
| |
872.6770 |
Cartridge syringe. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ear Nose & Throat |
| |
874.1090 |
Auditory impedance tester. |
II |
| |
874.1120 |
Electronic noise generator for audiometric testing. |
II |
| |
874.1325 |
Electroglottograph. |
II |
| |
874.1820 |
Surgical nerve stimulator/locator. |
II |
| |
874.3300 |
Hearing Aid. |
II |
| |
874.3310 |
Hearing aid calibrator and analysis system. |
II |
| |
874.3320 |
Group hearing aid or group auditory trainer. |
II |
| |
874.3330 |
Master hearing aid. |
II |
| |
874.3400 |
Tinnitus masker. |
II |
| |
874.3730 |
Laryngeal prosthesis (Taub design). |
II |
| |
874.4250 |
Ear, nose, and throat electric or pneumatic surgical drill. |
II |
| |
874.4490 |
Argon laser for otology, rhinology, and laryngology. |
II |
| |
874.4500 |
Ear, nose, and throat microsurgical carbon dioxide laser. |
II |
| |
874.4680 |
Bronchoscope (flexible or rigid) and accessories. |
II |
| |
874.4710 |
Esophagoscope (flexible or rigid) and accessories. |
II |
| |
874.4720 |
Mediastinoscope and accessories. |
II |
| |
874.4760 |
Nasopharyngoscope (flexible or rigid) and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Gastroenterology |
| |
876.1075 |
Gastroenterology-urology biopsy instrument. |
II |
| |
876.1500 |
Endoscope and accessories. |
I |
| |
876.1500 |
Endoscope and accessories. |
II |
| |
876.1725 |
Gastrointestinal motility monitoring system. |
II |
| |
876.4020 |
Fiberoptic light ureteral catheter. |
II |
| |
876.4270 |
Colostomy rod. |
II |
| |
876.4300 |
Endoscopic electrosurgical unit and accessories. |
II |
| |
876.4400 |
Hemorrhoidal ligator. |
II |
| |
876.4480 |
Electrohydraulic lithotriptor. |
II |
| |
876.4500 |
Mechanical lithotriptor. |
II |
| |
876.4620 |
Ureteral stent. |
II |
| |
876.4730 |
Manual gastroenterology-urology surgical instrument and accessories. |
I |
| |
876.4770 |
Urethrotome. |
II |
| |
876.5010 |
Biliary catheter and accessories. |
II |
| |
876.5090 |
Suprapubic urological catheter and accessories. |
II |
| |
876.5130 |
Urological catheter and accessories. |
II |
| |
876.5160 |
Urological clamp for males. |
I |
| |
876.5320 |
Nonimplanted electrical continence device. |
II |
| |
876.5365 |
Esophageal dilator. |
II |
| |
876.5470 |
Ureteral dilator. |
II |
| |
876.5520 |
Urethral dilator. |
II |
| |
876.5540 |
Blood access device and accessories. |
II |
| |
876.5665 |
Water purification system for hemodialysis. |
II |
| |
876.5820 |
Hemodialysis system and accessories. |
II |
| |
876.5880 |
Isolated kidney perfusion and transport system and accessories. |
II |
| |
876.5895 |
Ostomy irrigator. |
II |
| |
876.5980 |
Gastrointestinal tube and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General Hospital |
| |
880.2420 |
Electronic monitor for gravity flow infusion systems. |
II |
| |
880.2460 |
Electrically powered spinal fluid pressure monitor. |
II |
| |
880.2500 |
Spinal fluid manometer. |
II |
| |
880.2800 |
Sterilization process indicator. |
II |
| |
880.2910 |
Clinical electronic thermometer. |
II |
| |
880.5025 |
I.V. container. |
II |
| |
880.5045 |
Medical recirculating air cleaner. |
II |
| |
880.5090 |
Liquid bandage. |
I |
| |
880.5130 |
Infant radiant warmer. |
II |
| |
880.5200 |
Intravascular catheter. |
II |
| |
880.5400 |
Neonatal incubator. |
II |
| |
880.5410 |
Neonatal transport incubator. |
II |
| |
880.5430 |
Nonelectrically powered fluid injector. |
II |
| |
880.5440 |
Intravascular administration set. |
II |
| |
880.5450 |
Patient care reverse isolation chamber. |
II |
| |
880.5570 |
Hypodermic single lumen needle. |
II |
| |
880.5580 |
Acupuncture needle. |
II |
| |
880.5680 |
Pediatric position holder. |
I |
| |
880.5700 |
Neonatal phototherapy unit. |
II |
| |
880.5725 |
Infusion pump. |
II |
| |
880.5780 |
Medical support stocking. |
II |
| |
880.5860 |
Piston syringe. |
II |
| |
880.6100 |
Ethylene oxide gas aerator cabinet. |
II |
| |
880.6250 |
Non-powdered patient examination glove. |
I |
| |
880.6375 |
Patient lubricant. |
I |
| |
880.6500 |
Medical ultraviolet air purifier. |
II |
| |
880.6710 |
Medical ultraviolet water purifier. |
II |
| |
880.6740 |
Vacuum-powered body fluid suction apparatus. |
II |
| |
880.6760 |
Protective restraint. |
I |
| |
880.6850 |
Sterilization wrap. |
II |
| |
880.6860 |
Ethylene oxide gas sterilizer. |
II |
| |
880.6870 |
Dry-heat sterilizer. |
II |
| |
880.6880 |
Steam sterilizer. |
II |
| |
880.6885 |
Liquid chemical sterilants/high level disinfectants. |
II |
| |
880.6920 |
Syringe needle introducer. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Neurology |
| |
882.1020 |
Rigidity analyzer. |
II |
| |
882.1030 |
Ataxiagraph. |
I |
| |
882.1240 |
Echoencephalograph. |
II |
| |
882.1275 |
Electroconductive media. |
II |
| |
882.1310 |
Cortical electrode. |
II |
| |
882.1320 |
Cutaneous electrode. |
II |
| |
882.1330 |
Depth electrode. |
II |
| |
882.1340 |
Nasopharyngeal electrode. |
II |
| |
882.1350 |
Needle electrode. |
II |
| |
882.1400 |
Electroencephalograph. |
II |
| |
882.1420 |
Electroencephalogram (EEG) signal spectrum analyzer. |
I |
| |
882.1460 |
Nystagmograph. |
II |
| |
882.1480 |
Neurological endoscope. |
II |
| |
882.1540 |
Galvanic skin response measurement device. |
II |
| |
882.1550 |
Nerve conduction velocity measurement device. |
II |
| |
882.1560 |
Skin potential measurement device. |
II |
| |
882.1570 |
Powered direct-contact temperature measurement device. |
II |
| |
882.1610 |
Alpha monitor. |
II |
| |
882.1620 |
Intracranial pressure monitoring device. |
II |
| |
882.1835 |
Physiological signal amplifier. |
II |
| |
882.1845 |
Physiological signal conditioner. |
II |
| |
882.1855 |
Electroencephalogram (EEG) telemetry system. |
II |
| |
882.1870 |
Evoked response electrical stimulator. |
II |
| |
882.1880 |
Evoked response mechanical stimulator. |
II |
| |
882.1890 |
Evoked response photic stimulator. |
II |
| |
882.1900 |
Evoked response auditory stimulator. |
II |
| |
882.1950 |
Tremor transducer. |
II |
| |
882.4060 |
Ventricular cannula. |
I |
| |
882.4100 |
Ventricular catheter. |
II |
| |
882.4150 |
Scalp clip. |
II |
| |
882.4175 |
Aneurysm clip applier. |
II |
| |
882.4250 |
Cryogenic surgical device. |
II |
| |
882.4275 |
Dowel cutting instrument. |
II |
| |
882.4300 |
Manual cranial drills, burrs, trephines, and their accessories |
II |
| |
882.4305 |
Powered compound cranial drills, burrs, trephines, and their accessories. |
II |
| |
882.4310 |
Powered simple cranial drills, burrs, trephines, and their accessories. |
II |
| |
882.4360 |
Electric cranial drill motor. |
II |
| |
882.4370 |
Pneumatic cranial drill motor. |
II |
| |
882.4400 |
Radiofrequency lesion generator. |
II |
| |
882.4460 |
Neurosurgical head holder (skull clamp). |
II |
| |
882.4545 |
Shunt system implantation instrument. |
I |
| |
882.4560 |
Stereotaxic instrument. |
II |
| |
882.4700 |
Neurosurgical paddie. |
II |
| |
882.4725 |
Radiofrequency lesion probe. |
II |
| |
882.4800 |
Self-retaining retractor for neurosurgery. |
II |
| |
882.4840 |
Manual rongeur. |
II |
| |
882.4845 |
Powered rongeur. |
II |
| |
882.5070 |
Bite block. |
II |
| |
882.5235 |
Aversive conditioning device. |
II |
| |
882.5500 |
Lesion temperature monitor. |
II |
| |
882.5550 |
Central nervous system fluid shunt and components. |
II |
| |
882.5810 |
External functional neuromuscular stimulator. |
II |
| |
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief. |
II |
| |
882.5960 |
Skull tongs for traction. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Obstetrics/Gynecology |
| |
884.1050 |
Endocervical aspirator. |
II |
| |
884.1060 |
Endometrial aspirator. |
II |
| |
884.1100 |
Endometrial brush. |
II |
| |
884.1175 |
Endometrial suction curette and accessories. |
II |
| |
884.1185 |
Endometrial washer. |
II |
| |
884.1300 |
Uterotubal carbon dioxide insufflator and accessories. |
II |
| |
884.1560 |
Fetal blood sampler. |
II |
| |
884.1630 |
Colposcope. |
II |
| |
884.1660 |
Transcervical endoscope (amnioscope) and accessories. |
II |
| |
884.1690 |
Hysteroscope and accessories. |
II |
| |
884.1700 |
Hysteroscopic insufflator. |
II |
| |
884.1720 |
Gynecologic laparoscope and accessories. |
II |
| |
884.1730 |
Laparoscopic insufflator. |
II |
| |
884.2225 |
Obstetric-gynecologic ultrasonic imager. |
II |
| |
884.2600 |
Fetal cardiac monitor. |
II |
| |
884.2640 |
Fetal phonocardiographic monitor and accessories. |
II |
| |
884.2660 |
Fetal ultrasonic monitor and accessories. |
II |
| |
884.2675 |
Fetal scalp circular (spiral) electrode and applicator. |
II |
| |
884.2700 |
Intrauterine pressure monitor and accessories. |
II |
| |
884.2720 |
External uterine contraction monitor and accessories. |
II |
| |
884.2740 |
Perinatal monitoring system and accessories. |
II |
| |
884.2960 |
Obstetric ultrasonic transducer and accessories. |
II |
| |
884.2980 |
Telethermographic system. |
I |
| |
884.2982 |
Liquid crystal thermographic system. |
I |
| |
884.3200 |
Cervical drain. |
II |
| |
884.3575 |
Vaginal pessary. |
II |
| |
884.3900 |
Vaginal stent. |
II |
| |
884.4120 |
Gynecologic electrocautery and accessories. |
II |
| |
884.4160 |
Unipolar endoscopic coagulator-cutter and accessories. |
II |
| |
884.4260 |
Hygroscopic Laminaria cervical dilator. |
II |
| |
884.4340 |
Fetal vacuum extractor. |
II |
| |
884.4400 |
Obstetric forceps. |
II |
| |
884.4500 |
Obstetric fetal destructive instrument. |
II |
| |
884.4530 |
Obstetric-gynecologic specialized manual instrument. |
II |
| |
884.4550 |
Gynecologic surgical laser. |
II |
| |
884.4900 |
Obstetric table and accessories. |
II |
| |
884.5070 |
Vacuum abortion system. |
II |
| |
884.5100 |
Obstetric anesthesia set. |
II |
| |
884.5160 |
Powered breast pump. |
II |
| |
884.5250 |
Cervical cap. |
II |
| |
884.5300 |
Condom. |
II |
| |
884.5310 |
Condom with spermicidal lubricant. |
II |
| |
884.5350 |
Contraceptive diaphragm and accessories. |
II |
| |
884.5390 |
Perineal heater. |
II |
| |
884.5400 |
Menstrual cup. |
II |
| |
884.5425 |
Scented or scented deodorized menstrual pad. |
II |
| |
884.5460 |
Scented or scented deodorized menstrual tampon. |
II |
| |
884.5470 |
Unscented menstrual tampon. |
II |
| |
884.5960 |
Genital vibrator for therapeutic use. |
II |
| |
884.6100 |
Assisted reproduction needles. |
II |
| |
884.6110 |
Assisted reproduction catheters. |
II |
| |
884.6120 |
Assisted reproduction accessories. |
II |
| |
884.6130 |
Assisted reproduction microtools. |
II |
| |
884.6140 |
Assisted reproduction micropipette fabrication instruments. |
II |
| |
884.6150 |
Assisted reproduction micromanipulators and microinjectors. |
II |
| |
884.6160 |
Assisted reproduction labware. |
II |
| |
884.6170 |
Assisted reproduction water and water purification systems. |
II |
| |
884.6180 |
Reproductive media and supplements. |
II |
| |
884.6190 |
Assisted reproductive microscopes and microscope accessories. |
I |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ophthalmic |
| |
886.1120 |
Ophthalmic camera. |
II |
| |
886.1220 |
Corneal electrode. |
II |
| |
886.1250 |
Euthyscope. |
II |
| |
886.1300 |
Afterimage flasher. |
II |
| |
886.1360 |
Visual field laser instrument. |
II |
| |
886.1385 |
Polymethylmethacrylate (PMMA) diagnostic contact lens. |
II |
| |
886.1510 |
Eye movement monitor. |
II |
| |
886.1570 |
Ophthalmoscope. |
II |
| |
886.1630 |
AC-powered photostimulator. |
II |
| |
886.1640 |
Ophthalmic preamplifier. |
II |
| |
886.1670 |
Ophthalmic isotope uptake probe. |
II |
| |
886.1780 |
Retinoscope. |
II |
| |
886.1850 |
AC-powered slitlamp biomicroscope. |
II |
| |
886.1930 |
Tonometer and accessories. |
II |
| |
886.1945 |
Transilluminator. |
II |
| |
886.3400 |
Keratoprosthesis. |
II |
| |
886.4070 |
Powered corneal burr. |
I |
| |
886.4100 |
Radiofrequency electrosurgical cautery apparatus. |
II |
| |
886.4115 |
Thermal cautery unit. |
II |
| |
886.4150 |
Vitreous aspiration and cutting instrument. |
II |
| |
886.4170 |
Cryophthalmic unit. |
II |
| |
886.4250 |
Ophthalmic electrolysis unit. |
II |
| |
886.4300 |
Intraocular lens guide. |
I |
| |
886.4335 |
Operating headlamp. |
II |
| |
886.4370 |
Keratome. |
I |
| |
886.4390 |
Ophthalmic laser. |
II |
| |
886.4392 |
Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. |
II |
| |
886.4400 |
Electronic metal locator. |
II |
| |
886.4440 |
AC-powered magnet. |
II |
| |
886.4610 |
Ocular pressure applicator. |
II |
| |
886.4670 |
Phacofragmentation system. |
II |
| |
886.4690 |
Ophthalmic photocoagulator. |
II |
| |
886.4790 |
Ophthalmic sponge. |
II |
| |
886.5100 |
Ophthalmic beta radiation source. |
II |
| |
886.5916 |
Rigid gas permeable contact lens. |
II |
| |
886.5918 |
Rigid gas permeable contact lens care products. |
II |
| |
886.5925 |
Soft (hydrophilic) contact lens. |
II |
| |
886.5928 |
Soft (hydrophilic) contact lens care products. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Orthopedic |
| |
888.1100 |
Arthroscope. |
II |
| |
888.1240 |
AC-powered dynamometer. |
II |
| |
888.1500 |
Goniometer. |
I |
| |
888.3040 |
Smooth or threaded metallic bone fixation fastener. |
II |
| |
888.4580 |
Sonic surgical instrument and accessories/attachments. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Physical Medicine |
| |
890.1225 |
Chronaximeter. |
II |
| |
890.1375 |
Diagnostic electromyograph. |
II |
| |
890.1385 |
Diagnostic electromyograph needle electrode. |
II |
| |
890.1450 |
Powered reflex hammer. |
II |
| |
890.1850 |
Diagnostic muscle stimulator. |
II |
| |
890.3110 |
Electric positioning chair. |
II |
| |
890.3690 |
Powered wheeled stretcher. |
II |
| |
890.3800 |
Motorized three-wheeled vehicle. |
II |
| |
890.3850 |
Mechanical wheelchair. |
I |
| |
890.3860 |
Powered wheelchair. |
II |
| |
890.3880 |
Special grade wheelchair. |
II |
| |
890.3900 |
Standup wheelchair. |
II |
| |
890.3930 |
Wheelchair elevator. |
II |
| |
890.5100 |
Immersion hydrobath. |
II |
| |
890.5110 |
Paraffin bath. |
II |
| |
890.5150 |
Powered patient transport. |
II |
| |
890.5250 |
Moist steam cabinet. |
II |
| |
890.5275 |
Microwave diathermy. |
II |
| |
890.5290 |
Shortwave diathermy. |
II |
| |
890.5300 |
Ultrasonic diathermy. |
II |
| |
890.5360 |
Measuring exercise equipment. |
II |
| |
890.5500 |
Infrared lamp. |
II |
| |
890.5525 |
Iontophoresis device. |
II |
| |
890.5575 |
Powered external limb overload warning device. |
II |
| |
890.5650 |
Powered inflatable tube massager. |
II |
| |
890.5710 |
Hot or cold disposable pack. |
I |
| |
890.5850 |
Powered muscle stimulator. |
II |
| |
890.5860 |
Ultrasound and muscle stimulator. |
II |
| |
890.5880 |
Multi-function physical therapy table. |
II |
| |
890.5900 |
Power traction equipment. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Radiology |
| |
892.1000 |
Magnetic resonance diagnostic device. |
II |
| |
892.1100 |
Scintillation (gamma) camera. |
I |
| |
892.1110 |
Positron camera. |
I |
| |
892.1170 |
Bone densitometer. |
II |
| |
892.1200 |
Emission computed tomography system. |
II |
| |
892.1220 |
Fluorescent scanner. |
II |
| |
892.1310 |
Nuclear tomography system. |
II |
| |
892.1360 |
Radionuclide dose calibrator. |
II |
| |
892.1390 |
Radionuclide rebreathing system. |
II |
| |
892.1540 |
Nonfetal ultrasonic monitor. |
II |
| |
892.1550 |
Ultrasonic pulsed doppler imaging system. |
II |
| |
892.1560 |
Ultrasonic pulsed echo imaging system. |
II |
| |
892.1570 |
Diagnostic ultrasonic transducer. |
II |
| |
892.1600 |
Angiographic x-ray system. |
II |
| |
892.1610 |
Diagnostic x-ray beam-limiting device. |
II |
| |
892.1620 |
Cine or spot fluorographic x-ray camera. |
II |
| |
892.1630 |
Electrostatic x-ray imaging system. |
II |
| |
892.1650 |
Image-intensified fluoroscopic x-ray system. |
II |
| |
892.1660 |
Non-image-intensified fluoroscopic x-ray system. |
II |
| |
892.1670 |
Spot-film device. |
II |
| |
892.1680 |
Stationary x-ray system. |
II |
| |
892.1710 |
Mammographic x-ray system. |
II |
| |
892.1720 |
Mobile x-ray system. |
II |
| |
892.1730 |
Photofluorographic x-ray system. |
II |
| |
892.1740 |
Tomographic x-ray system. |
II |
| |
892.1750 |
Computed tomography x-ray system. |
II |
| |
892.1820 |
Pneumoencephalographic chair. |
II |
| |
892.1850 |
Radiographic film cassette. |
II |
| |
892.1860 |
Radiographic film/cassette changer. |
II |
| |
892.1870 |
Radiographic film/cassette changer programmer. |
II |
| |
892.1900 |
Automatic radiographic film processor. |
II |
| |
892.2030 |
Medical image digitizer. |
II |
| |
892.2040 |
Medical image hardcopy device. |
II |
| |
892.2050 |
Picture archiving and communications system. |
II |
| |
892.5050 |
Medical charged-particle radiation therapy system. |
II |
| |
892.5300 |
Medical neutron radiation therapy system. |
II |
| |
892.5700 |
Remote controlled radionuclide applicator system. |
II |
| |
892.5710 |
Radiation therapy beam-shaping block. |
II |
| |
892.5730 |
Radionuclide brachytherapy source. |
II |
| |
892.5750 |
Radionuclide radiation therapy system. |
II |
| |
892.5770 |
Powered radiation therapy patient support assembly. |
II |
| |
892.5840 |
Radiation therapy simulation system. |
II |
| |
892.5900 |
X-ray radiation therapy system. |
II |
| |
892.5930 |
Therapeutic x-ray tube housing assembly. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| General & Plastic Surgery |
| |
878.4040 |
Surgical apparel. |
II |
| |
878.4200 |
Introduction/drainage catheter and accessories. |
I |
| |
878.4350 |
Cryosurgical unit and accessories. |
II |
| |
878.4370 |
Surgical drape and drape accessories. |
II |
| |
878.4400 |
Electrosurgical cutting and coagulation device and accessories. |
II |
| |
878.4410 |
Low energy ultrasound wound cleaner. |
II |
| |
878.4460 |
Non-powdered surgeon's glove. |
I |
| |
878.4580 |
Surgical lamp. |
II |
| |
878.4630 |
Ultraviolet lamp for dermatologic disorders. |
II |
| |
878.4780 |
Powered suction pump. |
II |
| |
878.4810 |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
II |
| |
878.5040 |
Suction lipoplasty system. |
II |
| |
878.5070 |
Air-handling apparatus for a surgical operating room. |
II |
| top of page |
