Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TETLEY PATIENT ADMINISTRATION SET (K913416)Tetley Medical , Ltd.1991-10-28
FLEX-IV (K911251)Medway1991-10-28
ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR (K911965)Citizen Watch Co., Ltd.1991-10-28
SCEPTOR IDENTIFICATION SYSTEM (K912897)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-10-28
LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR (K914098)Surgical Innovations Corp.1991-10-28
CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE (K912987)Douglas James Donaldson Compliance Services1991-10-28
ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS (K914553)Invacare Corp.1991-10-28
OPUS(R) ANTI CMV-M (K913080)Pb Diagnostics, Inc.1991-10-28
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE (K913631)Advanced Cardiovascular Systems, Inc.1991-10-28
VISION (NUCLEAR MEDICINE COMPUTER) (K912573)Summit Nuclear1991-10-28
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION (K914090)Daig Corp.1991-10-28
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 (K912014)Empi1991-10-28
MONOSCOPY(TM) BRAND, ENDOBAG (K913762)Dexide, Inc.1991-10-28
KAR-D-TEK (K913405)Gresco Products, Inc.1991-10-28
STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) (K910778)Mdt Biologic Co.1991-10-28
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT (K913073)Biosearch Medical Products, Inc.1991-10-25
COX DISPOSABLE CYTOLOGY BRUSHES (K914466)Cox Medical Ent., Inc.1991-10-25
KPE 230 AM (K914172)Ipax, Inc.1991-10-25
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 (K913466)Em Diagnostic Systems, Inc.1991-10-25
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF (K914240)Unipath , Ltd.1991-10-25
VENTILATOR STAND (K914485)Bird Products Corp.1991-10-25
RAY SACRAL FIXATION SYSTEM (K904520)Danek Medical, Inc.1991-10-25
BIO TENS 601, 606 AND 608 (3000) (K912178)Skylark Device Co., Ltd.1991-10-25
STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES (K911354)Internacional Farmaceutica, S.A. DE C.V.1991-10-25
SCOPTOPIC SENSITIVITY TEST-1[SST-1] (K914163)Lkc Technologies, Inc.1991-10-25
TORQUE TUBE STEEROCATH(TM) (K913375)Ep Technologies, Inc.1991-10-25
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (K914442)Cox Medical Ent., Inc.1991-10-25
CIBA CORNING ACS T3 IMMUNOASSAY (K913646)Ciba Corning Diagnostics Corp.1991-10-25
IPS EMPRESS (K913372)Ivoclar North America, Inc.1991-10-25
FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 (K914125)Ferno1991-10-25
KPE 220 TS, NONSTERILE (K914221)Ipax, Inc.1991-10-25
VENTREX COATED TUBE INTACT PTH (K913434)Ventrex Laboratories, Inc.1991-10-25
MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (K913590)Dynatech Laboratories, Inc.1991-10-25
FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT (K911972)Intermedics Orthopedics1991-10-25
CROSSLINK PLATE (K911307)Danek Medical, Inc.1991-10-24
POSTERIOR NASAL EPISTAXIS INSTRUMENTS (K911756)Richard Wolf Medical Instruments Corp.1991-10-24
POLAR PADS (K914434)Breg, Inc.1991-10-24
GRAVITRON UPPER BODY SYSTEM EXERCISER (K912056)Tri-Tech, Inc.1991-10-24
TA620 TREADMILL CONTROLLER (K913518)Siemens Burdick, Inc.1991-10-24
510 DL POWERED WHEELCHAIRS (K913989)Am Scooters1991-10-24
OES THORACOSCOPE SYSTEM (K912362)Olympus Corp.1991-10-24
DUET BICYCLE/WHEELCHAIR (K913759)Robert Hoening Mobility Systems, Inc.1991-10-24
MULTI-REACH II WAND MASSAGER (K914344)Conair Corp.1991-10-24
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR (K911562)Continental X-Ray Corp.1991-10-24
GAUNTLET STAIR CLIMBER (K912058)Tri-Tech, Inc.1991-10-24
4000 PT EXERCISE SYSTEM (K912057)Tri-Tech, Inc.1991-10-24
DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 (K911584)Pie Medical Equipment B.V.1991-10-24
PIT AND FISSURE SEALANT PRODUCTS (K914319)Confi-Dental Products Co.1991-10-23
EMS PERCUSSOR (K913014)Engineered Medical Systems1991-10-23
CIBA CORNING MODEL 270 CO-OXIMETER (K913332)Ciba Corning Diagnostics Corp.1991-10-23
MULTIPLE LATEX PATIENT EXAMINATION GLOVES (K914049)London Rubber Co. (India) , Ltd.1991-10-23
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K914088)Bivona Medical Technologies1991-10-23
BIVONA CUFF MAINTENANCE DEVICE (CMD) (K914183)Bivona Medical Technologies1991-10-23
SWEMAC REISON BIPLANAR 300 (K911739)Seemac Reison AB Co.1991-10-23
DEXON DISSECTING SPONGE (K914365)Davis & Geck, Inc.1991-10-23
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER (K913734)Augustine Medical, Inc.1991-10-23
CLEARSITE(R) STERILE WOUND CARE DRESSING (K914207)Ndm Acquisition Corp.1991-10-23
FORTEX(TM) WOUND DRESSING (K914314)Calgon Vestal Div.1991-10-23
SPOON FORCEPS, 11MM (K911364)Northgate Technologies, Inc.1991-10-23
I.V. PRIMING SET (K913333)Gainor Medical Europe, Ltd.1991-10-23
.010 HI-TORQUE PLUS(TM) GUIDE WIRE (K913328)Advanced Cardiovascular Systems, Inc.1991-10-23
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY (K912079)3M Health Care, Sarns1991-10-23
HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (K911710)Sunscope Intl., Inc.1991-10-23
MOBILE X-RAY SYSTEM (K913525)Siemens Medical Solutions USA, Inc.1991-10-23
CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY (K912158)Medical Device Inspection Co., Inc.1991-10-23
VASCULAR GUIDE WIRE (K913353)Advanced Cardiovascular Systems, Inc.1991-10-23
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER (K914141)Cordis Corp.1991-10-23
STAMBI-CK (K913349)Intl. Immunoassay Laboratories, Inc.1991-10-23
MULTI-VIEW BIFOCALS (K913081)Camp Contact Lenses1991-10-23
MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (K913964)Marlo Surgical Technology1991-10-23
METERED DOSE INHALER (MDI) SPACER (K911807)Health Products, Inc.1991-10-23
MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM (K913630)Siemens Gammasonics, Inc.1991-10-23
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912504)Intertech Resources, Inc.1991-10-23
JTECH 50 SERIES CUTTING LOOP (K913587)J-Tech, Inc.1991-10-23
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION (K911726)Bausch & Lomb, Inc.1991-10-23
PROFESSIONAL INDIRECT OPHTHALMOSCOPE (K912397)Clement Clarke, Inc.1991-10-23
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (K914462)Serono-Baker Diagnostics, Inc.1991-10-23
UNIPOLAR UPSIZING ADAPTOR (K912773)Telectronics Pacing Systems, Inc.1991-10-23
DRUG NEBULIZERS (K911422)Intersurgical, Inc.1991-10-23
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL (K914439)Johnson & Johnson Orthopaedics, Inc.1991-10-23
BARITONE C2 & BARITONE L3 (K914322)Confi-Dental Products Co.1991-10-23
OCHSNER ULP BIFURCATION VASCULAR PROTHESIS (K913143)Intervascular, Inc.1991-10-23
ANOMALOSCOPE QUADRANT TEST-6 (K913962)Lkc Technologies, Inc.1991-10-23
CIRRUS GAMMA CAMERA (K913471)Adac Laboratories1991-10-23
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (K913753)B&B Medical Technologies, Inc.1991-10-23
INVENTOR RT/EXPLORER TRAUMA UNIT (K911563)Continental X-Ray Corp.1991-10-23
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED (K912065)Intertech Resources, Inc.1991-10-23
MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (K913266)Micro Surgical Instruments Corp.1991-10-21
MODEL 330 SCREENING AUDIOMETER (K911689)Virtual Corp.1991-10-21
LIPASE LINEARITY CONTROL (K913585)Creative Laboratory Products, Inc.1991-10-21
NIDEK MODELS AC-2100 & 2200 (K913465)Nidek, Inc.1991-10-21
LIMA RPS SHOULDER (K913282)Turnkey Intergration USA, Inc.1991-10-21
LOOK VISCODISSECTOR (K913530)Look, Inc.1991-10-21
MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT (K913441)Mri Devices Corp.1991-10-21
MERIT MANIFOLD (K913161)Merit Medical Systems, Inc.1991-10-21
FLO-GARD(R) 6200, 6300 & 8000 (K913895)Baxter Healthcare Corp1991-10-21
ABBOTT QUICKSTART LD-1,#5A30 (K914261)Em Diagnostic Systems, Inc.1991-10-21
F21(R) DENTAL CEMENT (K914073)Voco GmbH1991-10-21
8000 SERIES VOLUMETRIC PUMP SOLUTION SET (K914074)Baxter Healthcare Corp1991-10-21
DR. DEAN EDELL SOLARBLOC SUNGLASSES (K913640)Cable Car Sunglasses1991-10-21
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Track 1991 automatically

Every clearance here is in the API, with alerts when new ones post.