Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ADVANTAGE SIM (K951830)General Electric Co.1995-11-13
ASSERACHROM TOTAL PROTEIN S KIT (K954040)American Bioproducts Co.1995-11-13
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE) (K954336)Aust & Taylor Medical Corp.1995-11-13
SIEMENS MULTILEAF COLLIMATOR (K953894)Siemens Medical Solutions USA, Inc.1995-11-13
QUINTEST (K953939)Bayer Corp.1995-11-13
ASPECT DIGITAL FORMATTER (K954149)Aspect Electronics, Inc.1995-11-13
OTICON (K954794)Oticon, Inc.1995-11-13
CHROM Z CHROMOGENIC ASSAYS (K951943)Helena Laboratories1995-11-13
ARCHIVEMANAGER (K950513)Cemax, Inc.1995-11-13
OPERATING ARM SYSTEM (OAS) (K951262)Radionics Software Applications, Inc.1995-11-13
COAST HEARING CHS (CUSTOM HEARING SYSTEM) (K954937)Coast Hearing Services1995-11-13
JED-LIGHT FIBEROPTIC LIGHT SOURCE (K954184)Jedmed Instrument Co.1995-11-13
SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER (K953909)Scimed1995-11-13
ASSERACHROM FREE PROTEIN S KIT (K954017)American Bioproducts Co.1995-11-13
OB/GYN PACKS (K951081)Sterile Concepts, Inc.1995-11-13
AXSYM METHADONE (K953499)Abbott Laboratories1995-11-13
PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM (K952292)Puritan Bennett Corp.1995-11-13
PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K940188)Biomedical Sensors, Ltd.1995-11-13
CODMAN ANTERIOR CERVICAL PLATE SYSTEM (K953730)Johnson & Johnson Professionals, Inc.1995-11-09
SAFE-T-SEAL (K953829)Gs Medical Packaging, Inc.1995-11-09
5 LPM OXYGEN CONCENTRATOR (K953815)Devilbiss Health Care, Inc.1995-11-09
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] (K954174)Origin Medsystems, Inc.1995-11-09
TENS-IT, FITTRONIC II, (MORE LATER) (K946018)Ems, Inc.1995-11-09
NEUROREADER (K950986)Artronics1995-11-09
EXAMINATION PAD (K955094)Inventive Products, Inc.1995-11-09
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY (K952478)Boehringer Mannheim Corp.1995-11-09
IMMUCHEM GAL-MW EA (K951329)Icn Pharmaceuticals, Inc.1995-11-09
ORGEN TEC ANTI-DSDNA ELISA ASSAY (K953671)Orgentec1995-11-09
ABL SYSTEM 625, 615, 605 (K954612)Radiometer America, Inc.1995-11-09
HEARTHWATCH III(TM) (K945476)Instromedix, Inc.1995-11-09
FMS DUO (K954465)Future Medical Systems, Inc.1995-11-09
BUONAFEDE PNEUMATIC SLEEVE (K954201)Promedic, Inc.1995-11-09
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER (K951681)Fonar Corp.1995-11-09
MAS LIQUID URINALYSIS CONTROL (K954323)Medical Analysis Systems, Inc.1995-11-09
DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES] (K954175)Origin Medsystems, Inc.1995-11-09
SORBSAN PLUS TOPICAL WOUND DRESSING (K954230)Dow Hickam Pharmaceuticals, Inc.1995-11-08
ARTHROSCOPE (K942029)Surgical Technologies, Inc.1995-11-08
KIMONO MICROTHIN (K946374)Mayer Laboratories1995-11-08
SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3 (K953234)The Implant Center of the Palm Beaches1995-11-08
GENERAL HYGIENE KIT (K954068)Physician Industries, Inc.1995-11-08
FIRST CHOICE(TM) TEST STRIP (K946166)Polymer Technology Intl.1995-11-08
CARDIO-SYSTEMS PRO-OP (K953196)Ch Administration, Inc.1995-11-08
FIRST CHOICE TEST STRIP (K950628)Polymer Technology Intl.1995-11-08
DG EXAMINER PLUS (K953799)Medelec , Ltd.1995-11-08
DISPOSABLE PROPHY HANDPIECE (K954012)Denticator Intl., Inc.1995-11-08
RITE-ANGLE DISPOSABLE PROPHY ANGLES (K954802)Ash-USA1995-11-08
MARLENE STOCKINGS & TIGHTS (K954295)Professional Products, Inc.1995-11-08
AIR ENTRAINER 900RT008 (K953711)Fisher & Paykel Electronics , Ltd.1995-11-08
PESSARY FLEXIBLE SILICONE NICHOLS (K920633)Bioteque America, Inc.1995-11-08
AUTOJECT MINI (K953735)Owen Mumford USA, Inc.1995-11-08
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE (K950275)Zimmer, Inc.1995-11-07
EXCEL EMG (K941144)Excel Tech. , Ltd.1995-11-07
MODELS 5866-45 AND 5866-46 SIZING SLEEVE (K954085)Medtronic Vascular1995-11-07
MIKRO-TIP ANGIOGRAPHIC CATHETER (K952773)Millar Instruments, Inc.1995-11-07
SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM (K953779)Advanced Spine Fixation Systems, Inc.1995-11-07
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (K954913)Cardio Metrics, Inc.1995-11-07
EDM (K951369)Deltex Medical1995-11-07
CORDIS WIZDOM STEERABLE GUIDEWIRE (K953760)Cordis Corp.1995-11-07
SILCLEAR TUBING (MODIFICATION) (K953864)Degania Silicone , Ltd.1995-11-06
CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 (K953792)U.S. Medical Products, Inc.1995-11-06
MICRO-INGRESSOR HANDIPIECE (K954796)Trebay Medical Corp.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (K950480)Nikomed U.S.A., Inc.1995-11-06
ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (K954052)T. Korossurgical Instruments Corp.1995-11-06
KENTEX (K953914)Kentron Health Care, Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (K950471)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (K950477)Nikomed U.S.A., Inc.1995-11-06
COHORT(TM) ANTERIOR PLATE SYSTEM (APS) (K950011)Cohort Medical Products Group, Inc.1995-11-06
KARL STORZ TAKE-APART BIOPOLAR FORCEPS (K953809)KARL STORZ Endoscopy-America, Inc.1995-11-06
COAMATIC FACTOR VIII (K943225)Pharmacia Hepar, Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM (K950478)Nikomed U.S.A., Inc.1995-11-06
AVOXIMETER 4000 (K951485)A-Vox Systems, Inc.1995-11-06
PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (K954014)T. Korossurgical Instruments Corp.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (K950474)Nikomed U.S.A., Inc.1995-11-06
LUBINUS SP II HIP SYSTEM (K953653)Turnkey Intergration USA, Inc.1995-11-06
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM (K953778)Advanced Spine Fixation Systems, Inc.1995-11-06
CRYO CHECK LUPUS PLASMA (K952623)Precision Biologicals, Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (K950470)Nikomed U.S.A., Inc.1995-11-06
VENTANA BLUE DETECTION KIT (K940424)Ventana Medical Systems, Inc.1995-11-06
HUMAN TUBAL FLUID (K953719)Life Technologies, Inc.1995-11-06
SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (K954116)Technical Products, Inc.1995-11-06
DERRICK SAFETOUCH (K953709)M.P.S. Pharm'L Int'L1995-11-06
SURGICAL INTEGRATED CAMERA SYSTEM (K953438)Envision Medical Corp.1995-11-06
BARRAQUER-KRUMEICH REFRACTIVE SET (K954058)Eyetech M.V.A.1995-11-06
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) (K954418)Nichols Institute Diagnostics1995-11-03
NEXUS II FEMORAL COMPONENT (K954262)Wrightmedicaltechnologyinc1995-11-03
ACL FUTURA COAGULATION SYSTEM (K951891)Instrumentation Laboratory CO1995-11-03
XENON CIRCUIT (K953513)King Systems Corp.1995-11-03
KARL STORZ OPTICAL MEDIASTINOSCOPE (K954910)KARL STORZ Endoscopy-America, Inc.1995-11-03
PYRILINKS ASSAY KIT (K952506)Metra Biosystems, Inc.1995-11-03
IMEX 8000 PERSONAL CASCULAR LAB (K942243)Imex Medical Systems, Inc.1995-11-03
SYSMEX SF-3000 (K950508)Sysmex Corp.1995-11-03
PYRILINKS POLYCLONAL ASSAY KIT (K952026)Metra Biosystems, Inc.1995-11-03
FCP-9P, FIBER CHOLEDOCHOSCOPE (K953286)Pentax Precision Instrument Corp.1995-11-03
DEPUY STAINLESS STEEL SET SCREW (K953650)Depuy, Inc.1995-11-03
STERILE FEEDING TUBE (K954218)Baxter Healthcare Corp1995-11-03
THE SWIRLER AEROSOL SYSTEM (K952893)Amici, Inc.1995-11-03
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI (K954571)Princeton BioMeditech Corp.1995-11-03
MICROSPIN 24 (K953519)Vulcon Technologies1995-11-03
COMFORT-Q SUBCUTANEOUS INJECTION SETS (K946170)B. Braun of America, Inc.1995-11-03
LIP GRIP CAP HOLDER (K935916)Daryl C. Fallas1995-11-03
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Track 1995 automatically

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