This page provides information on organizations recognized by FDA to review submissions under the 510(k) Third Party Review Program (formally, the Accredited Persons Program) and the devices they may review. Product codes eligible to review by a specific 3P510k Review Organization are listed under the following regulations. Devices eligible for review by 3P510k Review Organizations are limited to the product codes shown on the list of eligible devices. You can look up a given product code in the product code database, browse by 3P510k review organization in the list below or browse by device area to confirm eligibility of your device.
As of August 13, 2021, Accelerated Device Approval Services, LLC (ADAS) is no longer recognized to conduct 510(k) Third Party Reviews. For details, see the Accreditation Status section on the 510(k) Third Party Performance Metrics and Accreditation Status page. |
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THIRD PARTY REVIEW GROUP, LLC
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| Panel | Section Number | Regulation Name / Device Name | Class |
| Anesthesiology |
| |
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 |
| |
868.2600 |
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 |
| |
868.5260 |
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 |
| |
868.5655 |
Portable liquid oxygen unit. |
II |
| |
868.5665 |
Powered percussor. |
II |
| |
868.5690 |
Incentive spirometer. |
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 |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Clinical Chemistry |
| |
862.1495 |
Magnesium test system. |
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 |
| |
870.2370 |
Electrocardiograph surface electrode tester. |
II |
| |
870.2400 |
Vectorcardiograph. |
II |
| |
870.2450 |
Medical cathode-ray tube display. |
II |
| |
870.2700 |
Oximeter. |
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 |
| |
870.4310 |
Cardiopulmonary bypass coronary pressure gauge. |
II |
| |
870.4330 |
Cardiopulmonary bypass on-line blood gas monitor. |
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 |
| |
870.4450 |
Vascular clamp. |
II |
| |
870.4475 |
Surgical vessel dilator. |
II |
| |
870.4500 |
Cardiovascular surgical instruments. |
I |
| |
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 |
| |
872.1740 |
Caries detection device. |
II |
| |
872.1745 |
Laser fluorescence 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 |
| |
872.3070 |
Dental amalgam, mercury, and amalgam alloy. |
II |
| |
872.3200 |
Resin tooth bonding agent. |
II |
| |
872.3240 |
Dental bur. |
I |
| |
872.3250 |
Calcium hydroxide cavity liner. |
II |
| |
872.3260 |
Cavity varnish. |
II |
| |
872.3275 |
Dental cement. |
II |
| |
872.3310 |
Coating material for resin fillings. |
II |
| |
872.3660 |
Impression material. |
II |
| |
872.3690 |
Tooth shade resin material. |
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 |
| |
872.3920 |
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 |
| |
872.4535 |
Dental diamond instrument. |
I |
| |
872.4730 |
Dental injecting needle. |
I |
| |
872.4840 |
Rotary scaler. |
II |
| |
872.4850 |
Ultrasonic scaler. |
II |
| |
872.4920 |
Dental electrosurgical unit and accessories. |
II |
| |
872.5410 |
Orthodontic appliance and accessories. |
I |
| |
872.5470 |
Orthodontic plastic bracket. |
II |
| |
872.5500 |
Extraoral orthodontic headgear. |
II |
| |
872.5570 |
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
II |
| |
872.5580 |
Oral rinse to reduce the adhesion of dental plaque. |
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 |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ear Nose & Throat |
| |
874.1090 |
Auditory impedance tester. |
II |
| |
874.3302 |
Hearing Aid, Bone Conduction |
II |
| |
874.3400 |
Tinnitus masker. |
II |
| |
874.4250 |
Ear, nose, and throat electric or pneumatic surgical drill. |
II |
| |
874.4420 |
Ear, nose, and throat manual surgical instrument. |
I |
| |
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 |
| |
874.4760 |
Nasopharyngoscope (flexible or rigid) and accessories. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Gastroenterology |
| |
876.1075 |
Gastroenterology-urology biopsy instrument. |
I |
| |
876.1075 |
Gastroenterology-urology biopsy instrument. |
II |
| |
876.1500 |
Endoscope and accessories. |
II |
| |
876.1725 |
Gastrointestinal motility monitoring system. |
II |
| |
876.4300 |
Endoscopic electrosurgical unit and accessories. |
II |
| |
876.4480 |
Electrohydraulic lithotriptor. |
II |
| |
876.4500 |
Mechanical lithotriptor. |
II |
| |
876.4620 |
Ureteral stent. |
II |
| |
876.4680 |
Ureteral stone dislodger. |
I |
| |
876.4680 |
Ureteral stone dislodger. |
II |
| |
876.5010 |
Biliary catheter and accessories. |
II |
| |
876.5090 |
Suprapubic urological catheter and accessories. |
II |
| |
876.5130 |
Urological catheter and accessories. |
II |
| |
876.5130 |
Urological catheter and accessories. |
N |
| |
876.5320 |
Nonimplanted electrical continence device. |
II |
| |
876.5470 |
Ureteral dilator. |
II |
| |
876.5520 |
Urethral dilator. |
II |
| |
876.5540 |
Blood access device and accessories. |
I |
| |
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 |
| |
876.5980 |
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 |
| |
880.5240 |
Medical adhesive tape and adhesive bandage. |
I |
| |
880.5400 |
Neonatal incubator. |
II |
| |
880.5410 |
Neonatal transport incubator. |
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 |
| |
880.5860 |
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 |
| |
880.6600 |
Ultraviolet (UV) radiation chamber disinfection device. |
II |
| |
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 |
| |
880.6992 |
Medical washer-disinfector. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Neurology |
| |
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 |
| |
882.1550 |
Nerve conduction velocity 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 |
| |
882.1870 |
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 |
| |
882.4100 |
Ventricular catheter. |
II |
| |
882.4150 |
Scalp clip. |
II |
| |
882.4175 |
Aneurysm clip applier. |
II |
| |
882.4190 |
Clip forming/cutting instrument. |
I |
| |
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 |
| |
882.4700 |
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 |
| |
882.5810 |
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 |
| |
866.6050 |
Ovarian adnexal mass assessment score test system. |
II |
| |
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. |
I |
| |
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 |
| |
884.3575 |
Vaginal pessary. |
II |
| |
884.3900 |
Vaginal stent. |
II |
| |
884.4120 |
Gynecologic electrocautery and accessories. |
II |
| |
884.4150 |
Bipolar endoscopic coagulator-cutter 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 |
| |
884.4500 |
Obstetric fetal destructive instrument. |
II |
| |
884.4530 |
Obstetric-gynecologic specialized manual instrument. |
II |
| |
884.4550 |
Gynecologic surgical laser. |
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 |
| |
884.5460 |
Scented or scented deodorized menstrual tampon. |
II |
| |
884.5470 |
Unscented menstrual tampon. |
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 |
| |
884.6160 |
Assisted reproduction labware. |
II |
| |
884.6170 |
Assisted reproduction water and water purification systems. |
II |
| Panel | Section Number | Regulation Name / Device Name | Class |
| Ophthalmic |
| |
886.1120 |
Ophthalmic camera. |
II |
| |
886.1220 |
Corneal electrode. |
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 |
| |
886.1850 |
AC-powered slitlamp biomicroscope. |
II |
| |
886.1930 |
Tonometer and accessories. |
II |
| |
886.3400 |
Keratoprosthesis. |
II |
| |
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 |
| |
886.4300 |
Intraocular lens guide. |
I |
| |
886.4350 |
Manual ophthalmic surgical instrument. |
I |
| |
886.4370 |
Keratome. |
I |
| |
886.4390 |
Ophthalmic laser. |
II |
| |
886.4392 |
Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. |
II |
| |
886.4610 |
Ocular pressure applicator. |
II |
| |
886.4670 |
Phacofragmentation system. |
II |
| |
886.4690 |
Ophthalmic photocoagulator. |
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 |
| 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 |
| |
890.1850 |
Diagnostic muscle stimulator. |
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 |
| |
890.5150 |
Powered patient transport. |
II |
| |
890.5275 |
Microwave diathermy. |
II |
| |
890.5290 |
Shortwave diathermy. |
II |
| |
890.5300 |
Ultrasonic diathermy. |
II |
| |
890.5500 |
Infrared lamp. |
II |
| |
890.5525 |
Iontophoresis 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 |
| |
892.1620 |
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 |
| |
892.1680 |
Stationary x-ray system. |
II |
| |
892.1710 |
Mammographic x-ray system. |
II |
| |
892.1715 |
Full-field digital mammography 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 |
| |
892.2050 |
Picture archiving and communications system. |
II |
| |
892.5710 |
Radiation therapy beam-shaping block. |
II |
| |
892.5720 |
Prostate Immobilizer Rectal Balloon |
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 |
| |
892.6510 |
Cream For X-Ray Attenuation |
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 |
| |
878.4635 |
Sunlamp products and ultraviolet lamps intended for use in sunlamp products. |
II |
| |
878.4780 |
Powered suction pump. |
II |
| |
878.4800 |
Manual surgical instrument for general use. |
I |
| |
878.4810 |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
II |
| |
878.5070 |
Air-handling apparatus for a surgical operating room. |
II |
| |
878.5400 |
Low level laser system for aesthetic use |
II |
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