Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AMR-ACV CLAMPS (K962668)Applied Medical Resources1996-11-04
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K963061)Beckman Instruments, Inc.1996-11-04
VEGA HEMATOLOGY ANALYZER (K962633)Abx, Inc.1996-11-04
EZ-FIX SMALL CANNULATED SCREW SYSTEM (K962987)Biodynamic Technologies, Inc.1996-11-04
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (K955122)Intermedics, Inc.1996-11-04
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE (K962584)Ethicon Endo-Surgery, Inc.1996-11-04
ALPCO/MERCODIA INSULIN ELISA (K963911)American Laboratory Products Co., Ltd.1996-11-01
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (K963042)Sim Italia S.R.L.1996-11-01
ENDOCAM (K963046)Corin USA1996-11-01
KARL STORZ REMORGIDA FORCEPS (K962083)KARL STORZ Endoscopy-America, Inc.1996-11-01
AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM (K961705)Applied Optronics Corp.1996-11-01
STP SYSTEM-PVA WITH MERCURY (K964027)Sage Products, Inc.1996-11-01
HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET (K963099)Heelbo, Inc.1996-11-01
SLEEPNET HUMIDIFIER,(84200 PACKAGED) (K963025)Sleepnet Corporation1996-11-01
HEELBO PELVIC RESTRAINT (K963199)Hollister, Inc.1996-11-01
MICRO SPIROMETER (K963035)Micro Direct, Inc.1996-11-01
WELLCOLEX E-COLI OI57 ZC60 (K962028)Murex Diagnostics, Inc.1996-11-01
FEMTEX GENTLE TOUCH TAMPONS (K963034)First Quality Hygienic, Inc.1996-11-01
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR (K961836)Medtronic Vascular1996-11-01
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (K961935)Sharplan Lasers, Inc.1996-11-01
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES (K961272)Nihon Kohden America, Inc.1996-11-01
SCUBA SYSTEM (K962482)Gynecare, Inc.1996-11-01
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM (K961710)Applied Optronics Corp.1996-11-01
COMBILINES HEMODIALYSIS BLOOD TUBING SET (K962081)National Medical Care, Medical Products Div., Inc.1996-11-01
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550)Respironics, Inc.1996-11-01
HEMOCUE GLUCOTROL (K964053)Direct Solutions1996-11-01
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION (K943824)Ametek, Inc.1996-11-01
MORRISON MEDICAL WRIST RESTRAINT (K963419)Morrison Medical Products1996-10-31
MRS-2D (K961645)Lexicor Medical Technology, Inc.1996-10-31
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS (K962993)Cynosure, Inc.1996-10-31
AUTOMATIC TUBING CLAMP SYSTEM (ATC) (K961364)Rocky Mountain Research, Inc.1996-10-31
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS (K961784)Sienna Biotech, Inc.1996-10-31
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT (K963393)Depuy, Inc.1996-10-31
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS (K963292)Roche Diagnostic Systems, Inc.1996-10-31
V-LINK 3.2 FOR WINDOWS (K963274)Koven Technology, Inc.1996-10-31
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (K963527)Alimed, Inc.1996-10-31
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE (K960590)Aladan Corp.1996-10-31
ASTA-CATH (K961361)A+ Products1996-10-31
NEUROMAG-122 (K962764)Philips Medical Systems (Cleveland), Inc.1996-10-31
HEELBO LIFE JACKET WITH CROTCH SUPPORT (K963041)Heelbo, Inc.1996-10-31
EZ-SCREEN PROFILE (K963233)Editek, Inc.1996-10-31
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM (K961621)Therapy Concepts, Inc.1996-10-31
3M PROPLUS SYSTEM (K963766)3M Company1996-10-31
BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE (K963218)American Bantex Corp.1996-10-30
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 (K963543)Sigma Diagnostics, Inc.1996-10-30
CEDIA DAU OPIATE 2K ASSAY (K962795)Boehringer Mannheim Corp.1996-10-30
COULTER GEN-S SYSTEM (K962988)Coulter Corp.1996-10-30
VERDICT BARBITURATES (K963529)Editek, Inc.1996-10-30
INSTANT COLD PACK (K963666)Kick Ice, Inc.1996-10-30
LEVO COMPACT LC (K963816)Levo USA1996-10-30
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR (K954850)C.R. Bard, Inc.1996-10-30
BARD QUANTUM CVR (K962726)C.R. Bard, Inc.1996-10-30
BIODERM PVP FOAM WOUND DRESSING (K963602)Bioderm, Inc.1996-10-30
IMX FREE TRIIODOTHYRONINE (FREE T3) (K963833)Abbott Laboratories1996-10-30
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) (K963188)Codi International BV1996-10-30
AXSYM FREE TRIIODOTHYRONINE (FREE T3) (K963827)Abbott Laboratories1996-10-30
VISUALINE COMBO V (COCAINE/THC) TEST (K963606)Sun Biomedical Laboratories, Inc.1996-10-30
RMS K-WIRE (K963367)Rms Div.1996-10-30
VERDICT THC (K963516)Editek, Inc.1996-10-30
CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306)Boehringer Mannheim Corp.1996-10-29
DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595)Netech Corp.1996-10-29
HELAX TMS BRACHYTHERAPY, VERSION 3.0 (K962892)Siemens Medical Solutions USA, Inc.1996-10-29
STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED (K962724)Sonnheim Medikal GmbH1996-10-29
PM SYNTHETIC MEDICAL GLOVES, POWDER FREE (K963797)Shanghai PM Plastics Enterise Co., Ltd.1996-10-29
PICO MODELS 30, 50, 70 (K962158)Radiometer America, Inc.1996-10-29
ELS AUTOMATIC TUBING CLAMP SYSTEM (K961598)Rocky Mountain Research, Inc.1996-10-29
PT SYNTHETIC MEDICAL GLOVES, POWDER FREE (K963751)Shanghai PT Plastics Enterprise Company, Ltd.1996-10-29
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER (K963378)Medline Industries, Inc.1996-10-29
ALGINMAX, ORTHOCHROME (K963205)American Tooth Industries1996-10-29
MINI SAMPLE PROCESSOR (K962859)Cavro Scientific Instruments, Inc.1996-10-29
MEDLINE OPEN END FINGER CONTROL MITT (K963504)Medline1996-10-29
BARD TIGER GUIDEWIRE MODEL 000540 (K962178)C.R. Bard, Inc.1996-10-29
GC BASELINE (K963144)GC America, Inc.1996-10-29
CEDIA CARDIAC TDM MULTI-CALS (K962269)Boehringer Mannheim Corp.1996-10-29
HEARSAVER (K962292)Emtech Laboratories1996-10-29
PRESSURE STOPCOCK/MANIFOLD (K960431)Scientific Device Manufacturer, LLC1996-10-29
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) (K963528)Alimed, Inc.1996-10-29
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 (K963533)Sigma Diagnostics, Inc.1996-10-29
SONOLINE ELEGRA WITH SIESCAPE FEATURE (K961833)Siemens Medical Solutions USA, Inc.1996-10-29
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 (K962714)Passy-Muir, Inc.1996-10-28
OVATION AGC-3 (K963822)Orsonique, Inc.1996-10-28
OVATION AGC-1 (K963821)Orsonique, Inc.1996-10-28
OVATION LINEAR (K963820)Orsonique, Inc.1996-10-28
RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES (K963219)Fci Ophthalmics, Inc.1996-10-28
RADIAS GALT TEST (K961432)Bio-Rad1996-10-28
MEDI-TRACE 200, MEDI-TRACE 200-30 (K960968)Graphic Controls Corp.1996-10-28
EUREDUC PNEUMATIC DRAINAGE SYSTEM (K954788)Eureduc1996-10-28
OVATION ASP (K963819)Orsonique, Inc.1996-10-28
SYSMEX UF-100 (K961054)Sysmex Corp.1996-10-28
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE (K960299)Richard Wolf Medical Instruments Corp.1996-10-28
TBD (K963026)Acu Med, Inc.1996-10-28
FUJI MEDICAL DRY IMAGER FM-DP 2636 (K962967)Fujifilm Medical System U.S.A., Inc.1996-10-28
BIO BOOST (K961426)Bio Compression Systems, Inc.1996-10-28
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS (K961425)Bio Compression Systems, Inc.1996-10-28
VACUUM CUP (004SD) (K963287)Swift Delivery Products1996-10-28
STRAP WEDGE (K963526)Alimed, Inc.1996-10-28
GAMMACON IMAGE TRANSLATION SYSTEM (K962955)Medical Imaging Technology Assoc., Inc.1996-10-28
CONVERTORS POLYOLEFIN FABRIC GOWNS (K961341)Baxter Healthcare Corp1996-10-28
OVATION AGC-2 (K963818)Orsonique, Inc.1996-10-28
LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS (K963740)Howmedica Leibinger, Inc.1996-10-28
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Track 1996 automatically

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