Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP (K943287)Ndm Acquisition Corp.1994-12-27
PSI FLEXIBLE ARM (K942601)V. Mueller Neuro/Spine1994-12-27
SOFT SOCK (K944240)Silipos, Inc.1994-12-27
DISPOSABLE GAS SAMPLING LINES (K946044)Catheter Research, Inc.1994-12-27
VISUALIZER 2000 (K943272)Vf-Works, Inc.1994-12-27
COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION (K944720)Nuccardiac Software, Inc.1994-12-23
FLUFF GAUXZE ROLL (K945019)Clinical Resources, Inc.1994-12-23
WIDEX MODEL LOGO - L9 (K945703)Widex Hearing Aid Co., Inc.1994-12-23
FLUFF GAUZE SPONGE (K945020)Clinical Resources, Inc.1994-12-23
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER (K936091)Medtronic Bio-Medicus, Inc.1994-12-23
IN-THE-EAR HEARING AID (K945710)Truetone Hearing Systems, Inc.1994-12-23
FIELD ABUTMENT WEDGE (K943343)Medtec, Inc.1994-12-23
CHAKOFF ENDOSCOPY (K945421)Stephen Chakoff, Inc.1994-12-23
SUPERSENSOR MRI COIL (K941582)Superconductor Technologies, Inc.1994-12-23
SHAVE PREP KIT (K945481)Harding Industries, Inc.1994-12-23
RIT 531 TELERADIOLOGY/ PAC SYSTEM (K944130)Radiological Imaging Technology, Inc.1994-12-23
GAUZE SPONGES (K944879)Clinical Resources, Inc.1994-12-23
BTP-A HEARING SYSTEM (K944043)Resound Corp.1994-12-23
FLUFF GAUZE SPONGE (K945021)Clinical Resources, Inc.1994-12-23
FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561)Fujifilm Medical System U.S.A., Inc.1994-12-23
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS (K945527)KARL STORZ Endoscopy-America, Inc.1994-12-23
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR (K942613)Koven Technology, Inc.1994-12-23
TUNGSTEN EYESHIELD (K943011)Medtec, Inc.1994-12-23
TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (K934348)Tri-Med Specialties, Inc.1994-12-23
CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM (K943097)Global Medical Technologies, Inc.1994-12-23
ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (K942770)Ultimate Development Corp.1994-12-23
GENERAL ANESTHESIA SYSTEM (K945455)Vital Signs, Inc.1994-12-23
BEHIND THE EAR HEARING AID (K944039)Audicraft Hearing Instruments1994-12-23
LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES (K944681)Birtcher Medical Systems, Inc.1994-12-22
CROSSTEX SELF-SEALING STERILIZATION POUCH (K941327)Cross Country Paper Products Corp.1994-12-22
VARELISA CENTROMERE ANTIBODIES (K944171)Elias U.S.A., Inc.1994-12-22
S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP (K945929)Sscor1994-12-22
HEMOLAB (K931992)Biomerieux Vitek, Inc.1994-12-22
JAMES LECKEY FREE STANDER (K944308)James Leckey Design1994-12-22
AGEE-WRISTJACK PRE-DRILL KIT (K942906)Hand Biomechanics Lab, Inc.1994-12-22
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR (K923739)Abtox, Inc.1994-12-22
BIOMERIEUX HEMOLAB AT III (K934156)Biomerieux Vitek, Inc.1994-12-22
SONICAID MODEL P110 FETAL HEAR DETECTOR (K933816)Oxford Instruments, Plc.1994-12-22
VARELISA SM ANTIBODIES (K944170)Elias U.S.A., Inc.1994-12-22
360 SLX ADVISORY DEFIBRILLATOR (K935922)Medical Research Laboratories, Inc.1994-12-22
VARELISA JO-1 ANTIBODIES (K944173)Elias U.S.A., Inc.1994-12-22
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K944112)GE Medical Systems1994-12-22
ARCTIC PREMIER SERIES (K944700)Sungold Eyewear, Inc.1994-12-22
VARELISA RO (SS-A) ANTIBODIES (K944169)Elias U.S.A., Inc.1994-12-22
ABTOX PLAZLYTE PROCESS MONITOR (K923442)Abtox, Inc.1994-12-22
AUTOSTAT II ANTI-THYROGLOBULIN (K943625)Cogent Diagnotics , Ltd.1994-12-22
VARELISA SCL-70 ANTIBODIES (K944172)Elias U.S.A., Inc.1994-12-22
PM3300 INTERMITTENT VACUUM (K944479)Precision Medical, Inc.1994-12-22
PLAZLYTE(TM) (K905119)Abtox, Inc.1994-12-22
OPTICA 100 SUPERPULSED LASER SYSTEM (K944749)Xintec Corporation1994-12-22
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES (K945777)Smiths Industries Medical Systems, Inc.1994-12-22
HEMOLAB PROTEIN C CHROMOGENIC ASSAY (K934210)Biomerieux Vitek, Inc.1994-12-22
JAMES LECKEY PRONE STANDER (K944307)James Leckey Design1994-12-22
VARELISA LA (SS-B) ANTIBODIES (K944168)Elias U.S.A., Inc.1994-12-22
VARELISA RNP-SM ANTIBODIES (K944167)Elias U.S.A., Inc.1994-12-22
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (K945146)Promex, Inc.1994-12-21
IMAGE (K944161)Authorized Hearing Systems, Inc.1994-12-21
BRONCHOSCOPE,NON-RIGID (K944976)Citation Medical Corp.1994-12-21
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES (K944795)KARL STORZ Endoscopy-America, Inc.1994-12-21
ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES (K943055)Megadyne Medical Products, Inc.1994-12-21
FINETONE DISCEET CANAL (K945780)Finetone Hearing Instruments1994-12-21
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (K944944)Promedical , Ltd.1994-12-21
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR (K944012)Aspen Laboratories, Inc.1994-12-21
DEEP CANAL HEARING INSTRUMENT (K942702)Rexton, Inc.1994-12-21
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 (K944301)Hudson Respiratory Care, Inc.1994-12-21
UNSCENTED MENSTRUAL TAMPONS (K944834)Tambrands, Inc.1994-12-21
KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE (K945237)KARL STORZ Endoscopy-America, Inc.1994-12-21
ACTIVE MODEL CIC (K945218)Active Electronics, Inc.1994-12-21
APOGEE HIP STEM WITH POROCOAT (K934334)Depuy, Inc.1994-12-21
TROCAR/CANNULA (K945979)Endoscopic Technologies, Inc.1994-12-21
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729)Coast Medical, Inc.1994-12-21
CONMED TROGARD (K934799)Conmedcorp1994-12-21
DARWIN KNEE SYSTEM (K943462)Johnson & Johnson Professionals, Inc.1994-12-21
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES (K940729)Pioneer Surgical Technology1994-12-21
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ (K943176)KARL STORZ Endoscopy-America, Inc.1994-12-21
EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS (K945975)Everest Medical Corp.1994-12-21
P.F.C. CEMENT PRESSURIZING SYSTEM (K943906)Johnson & Johnson Professionals, Inc.1994-12-21
DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION (K935985)Deroyal Industries, Inc.1994-12-21
BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST (K944735)Bio-Logic Systems Corp.1994-12-21
KREATIV MODEL KV-1 (K940776)Kreativ, Inc.1994-12-21
JENERIC/PENTRON P0WERED TOOTHBRUST (K944084)Jeneric/Pentron, Inc.1994-12-20
OREX O.R. TOWEL (K942228)Thantex Specialties, Inc.1994-12-20
KLENZYME (K944950)Calgon Corp.1994-12-20
FOCUS BALLOON DILATATION CATHETER (K944016)Cardiovascular Dynamics, Inc.1994-12-20
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS (K946023)KARL STORZ Endoscopy-America, Inc.1994-12-20
PRIMED RIGID CONTAINER SYSTEM (K944864)Primed, Inc.1994-12-20
CG DISPOSABLE SYRINGE (K944920)Fortunique Medical Products1994-12-20
WINNER SELF-TAKING HOME BLOOD PRESSURE KIT (K942163)Winmed Instruments Mfg. Corp.1994-12-20
PROSTHOFLEX (K942562)Knopf Assoc, Inc.1994-12-20
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL (K944138)Baxter Healthcare Corp1994-12-20
TRANSTIBIAL ACL DISPOSABLES KIT (K943943)Arthrex, Inc.1994-12-20
BONE SCREW WASHER (K943782)Acu Med, Inc.1994-12-20
SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K945462)Block Drug Company, Inc.1994-12-20
INFRA VISION IMAGING SYSTEM (K945297)Gabriel Medical, Inc.1994-12-20
CVD SMALL VESSEL BALLOON DILATATION CATHETER (K945465)Cardiovascular Dynamics, Inc.1994-12-20
AXSYM DIGOXIN (K944506)Abbott Laboratories1994-12-19
MICROJECT MODEL 200, MODEL 30, AND MODEL TPN-5 (K941595)Microject, Inc.1994-12-19
ENDURANCE R3000 (K942384)Essential Medical Supply, Inc.1994-12-19
THE PROMPT GUIDWIRE (K943522)Cordis Corp.1994-12-19
CORVAC PLASTIC BLOOD COLLECTION TUBE (K944814)Sherwood Medical Co.1994-12-19
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Every clearance here is in the API, with alerts when new ones post.