Atlas FDA

1995

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

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RecordFirmDate
RW RESUCITAIRE INFANT RADIANT WARMER (K940951)Air-Shields, Inc.1995-05-03
MIST REDUCER SLEEVES (K951398)Minimally Invasive Surgical Technologies, Inc.1995-05-03
ISOTRON III (K941815)Excel Tech. , Ltd.1995-05-03
MIST TROCARS (K951480)Mist, Inc.1995-05-03
MANUAL SURGICAL INSRUMENT (K951589)United States Surgical, A Division of Tyco Healthc1995-05-03
MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT (K945845)Micos Medical Systems1995-05-03
MIST ENDOSCOPIC PROBES (K951692)Mist, Inc.1995-05-03
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (K925469)J.J. Skinner, Inc.1995-05-03
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE (K943938)Neward Enterprises, Inc.1995-05-03
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI (K944978)Bennett X-Ray Corp.1995-05-03
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2) (K951312)Sherwood Medical Co.1995-05-03
CERAMAFLEX BRACKET SYSTEM (K950992)Tp Orthodontics, Inc.1995-05-03
OR TOWEL (K941802)Hermitage Hospital Products, Inc.1995-05-03
QCT-BONE MINERAL ANALYSIS PHANTOM (K941126)Image Analysis, Inc.1995-05-03
BONE CUTTING INSTRUMENT AND ACCESSORIES (K950446)Steri-Oss, Inc.1995-05-03
DELTON F PIT & FISSURE SEALANT (K951296)Dentsply Intl.1995-05-03
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03
GEMINI (K950387)Spegas Industries, Ltd.1995-05-03
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) (K945185)KARL STORZ Endoscopy-America, Inc.1995-05-03
BURR, CORNEAL, BATTERY-POWERED (K950520)Aaron Medical Industries1995-05-02
FX-2P NMS (2 CHANNEL PORTABLE) (K945508)Fx-21995-05-02
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (K935598)Clinical Controls, Inc.1995-05-02
IN-CERAM SPINELL (K951183)Vident1995-05-02
DISPOSABLE PROPHYLAXIS ANGLE (K951016)Preventive Technologies, Inc.1995-05-02
FX-2 NMS (2CHANNEL TABLE MODEL) (K945509)Fx-21995-05-02
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS (K946250)Strato Medical Corp.1995-05-02
C-SERIES HOMEPUMP (K944692)Block Medical, Inc.1995-05-02
NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED (K942784)Norfolk Medical Products, Inc.1995-05-02
NEPHRETECT (K934066)Alden Scientific, Inc.1995-05-02
2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE (K940483)Neuro Navigational Corp.1995-05-02
CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY (K950921)Nichols Institute Diagnostics1995-05-02
DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH (K912521)Bud Industries, Inc.1995-05-02
POWER RANGERS SUNGLASSES (K951008)Siegel,Mandell & Davidson,P.C.1995-05-02
TDX(R)/TDXFLX(R) FREE PHENYTOIN II (K950280)Abbott Laboratories1995-05-02
POLARIS (K950388)Spegas Industries, Ltd.1995-05-02
FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K950292)Miles, Inc.1995-05-02
INDEX ACETABULAT COMPONENT (K950761)Biomet, Inc.1995-05-02
CEDIA DAU PROPOXYPHENE ASSAY (K951133)Microgenics Corp.1995-05-02
HICHEM Y-GT REAGENT KIT (K946192)Hichem Diagnostics1995-05-02
VISUALINE II CANNABINOIDS (THC) (K950445)Sun Biomedical Laboratories, Inc.1995-05-02
BRAINTRACE (K940811)Brainstorms Monitoring Corp.1995-05-02
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360)Bayer Corp.1995-05-02
FX-4 NMS (4CHANNEL TABLE MODEL) (K945510)Fx-21995-05-02
TYTIN ADMIX (K951511)Kerr Corporation (Danbury)1995-05-02
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (K951435)Aalto Scientific, Ltd.1995-05-02
E TEST FOR OFLOXACIN (K946364)Ab Biodisk1995-05-02
WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS (K943978)Waters Chromatography Division1995-05-02
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS (K945115)Biomet, Inc.1995-05-02
AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638)Organon Teknika Corp.1995-05-02
FINGERPRINT-DOA (K942836)Fingerprint Bioteck, Inc.1995-05-01
MECHANICAL WHEELCHAIR- IMPACT (K945152)Colours 'N Motion1995-05-01
HYPO(R) SAFETY CARTRIDGE SYRINGE (K936040)Smith & Nephew, Inc.1995-05-01
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2) (K951411)Sherwood Medical Co.1995-05-01
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE (K951393)Solomon Technology Labs1995-05-01
IL TEST PHENYTION CALIBRATORS (K943980)Instrumentation Laboratory CO1995-05-01
MICRO-ENDO(TM) INSTRUMENTS (K950130)Sofamor Danek USA,Inc.1995-05-01
STC DIAGNOSTIC 8000 (K935368)Sherman Technology Corp.1995-05-01
ELVIS HSV (K941924)Diagnostic Hybrids, Inc.1995-05-01
ACCUMETER HDL CHOLESTEROL TEST (K943279)Chemtrak, Inc.1995-05-01
SCIMED SCEPTOR PTCA GUIDE WIRE (K950534)Scimed Life Systems, Inc.1995-04-28
PRECEDER GUIDEWIRE (K950352)Boston Scientific Corp1995-04-28
BABYTHERM 8000 WB (K945467)Drager, Inc.1995-04-28
SCIPOTEX (PINK) (K951455)Wembley Rubber Products (M) Sdn Bhd1995-04-28
MD400 A/B/C/D/E/F/G (K944385)International Purification Systems, Inc.1995-04-28
SILASTIC BRAND FOLEY CATHETER (K951103)C.R. Bard, Inc.1995-04-28
SCIPOTEX (BLUE) (K951456)Wembley Rubber Products (M) Sdn Bhd1995-04-28
CG-1000 PERSONAL ECG TRANSMITTER (K935909)Card Guard Scientific Survival , Ltd.1995-04-28
DYNA IMPLANT DESIGN (K930868)Dyna Dental Engineering BV1995-04-28
ULTIMAX (K951467)Wembley Rubber Products (M) Sdn Bhd1995-04-28
COMFIT (K951468)Wembley Rubber Products (M) Sdn Bhd1995-04-28
NONE-GENERIC (K940724)Top Fashion Optical & Sunglasses1995-04-28
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA (K944267)Cobe Cardiovascular, Inc.1995-04-28
SIMON NITINOL FILTER (K944353)Nitinol Medical Technologies, Inc.1995-04-28
SCIMED SCEPTOR EXCHANGE GUIDE WIRE (K950535)Scimed Life Systems, Inc.1995-04-28
PRO-VIT (K950799)M. Imonti and Associates Inc.,1995-04-28
ELLMAN VAPOR-VAC II (K944558)North American Technical Services Corp.1995-04-28
SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES (K951504)Sunnex Fashion Corp.1995-04-28
SENSORI-MOTOR RATING SCALE (K946114)Cmed1995-04-28
COMFEEL PLUS CONTOUR DRESSING (K951327)Richard Hamer Assoc., Inc.1995-04-28
SMART DOSE(TM) (K943692)River Medical, Inc.1995-04-28
HEMOCHRON HNPT/FACTOR VI PT+ (K945078)International Technidyne Corp.1995-04-28
SCIPOTEX (K945785)Wembley Rubber Products (M) Sdn Bhd1995-04-28
VILA (K951381)Health-Dent Intl., Inc.1995-04-27
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (K942689)Ranir/Dcp Corp.1995-04-27
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION (K951378)Resound Corp.1995-04-27
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS (K945371)Standard Textile Co., Inc.1995-04-27
FUJINON VIDEO LAPORASCOPE (K933544)Fujinon, Inc.1995-04-27
ELECTRODES (K944992)Linvatec Corp.1995-04-27
SERIES 400 GASTROENTEROLOGY SYSTEM (K944620)Marks & Murase1995-04-27
BARD FLEXIBLE TIP URETERAL CATHETER (K950300)C.R. Bard, Inc.1995-04-27
COLGATE PRECISION MINT WZXED DENTAL FLOSS (K944886)Colgate-Palmolive Co.1995-04-27
MOYCO-EDTA (K950365)Union Broach, Div. Moyco Industries, Inc.1995-04-27
BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA (K950700)C.R. Bard, Inc.1995-04-27
ORAL-B ULTRAFLOSS WITH FLLUORIDE (K943157)Oral-B Laboratories1995-04-27
VENTIMASK MK IV (K951652)Flexicare Medical, Ltd.1995-04-27
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER (K950522)Baxter Healthcare Corp1995-04-27
VILA PC (K951380)Health-Dent Intl., Inc.1995-04-27
IMX(R) TOXO IGM (K945634)Abbott Laboratories1995-04-27
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER (K950454)Baxter Healthcare Corp1995-04-27
10.5MM REPLICA HIP STEM (K951095)Depuy, Inc.1995-04-27
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Every clearance here is in the API, with alerts when new ones post.