Atlas FDA

1994

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

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RecordFirmDate
COAT-A-COUNT FREE ESTRIOL (K932989)Diagnostic Products Corp.1994-12-19
IMMULITE RAPID TSH (K933212)Diagnostic Products Corp.1994-12-19
ABBOTT CHAGAS ANTIBODY EIA (K933716)Abbott Laboratories1994-12-19
IMMULITE ALATOP ALLERGY SCREEN (K941564)Diagnostic Products Corp.1994-12-19
PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (K943317)Diagnostic Products Corp.1994-12-19
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (K944275)Difco Laboratories, Inc.1994-12-19
OREX (K940764)Thantex Specialties, Inc.1994-12-19
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY (K935399)Bio-Rad1994-12-19
TOTAL TOE SYSTEM II (K941650)Biomet, Inc.1994-12-19
RING ELECTRODE (K933805)Cadwell Laboratories, Inc.1994-12-19
ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE (K942935)Reliant Technologies, Inc.1994-12-19
OREX (12X12 X-RAY DETECTABLE) (K940767)Thantex Specialties, Inc.1994-12-19
ANTERIOR CERVIAL PLATING SYSTEM (K943523)Smith & Nephew Richards, Inc.1994-12-19
IMMULITE THIRD GENERATION (MODIFICATION) (K940006)Diagnostic Products Corp.1994-12-19
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS (K944895)Bausch & Lomb, Inc.1994-12-19
ISOLYSER (K940765)Thantex Specialties, Inc.1994-12-19
IMMULITE PROGESTERONE (K944211)Diagnostic Products Corp.1994-12-19
ABBOTT IMX 2 ANALYZER (K944731)Abbott Laboratories1994-12-19
RESTORATION ACETABULAR CUP (K943549)Osteonics Corp.1994-12-19
OREX (18X18 X-RAY DETECTABLE) (K940766)Thantex Specialties, Inc.1994-12-19
STERISURE STERILIZATION WRAP (K944854)Fiberweb North America, Inc.1994-12-19
IMX RUBELLA IGM ANTIBODY ASSAY (K931059)Abbott Laboratories1994-12-19
SPIFFY (K945650)Thames Valley Children'S Centre1994-12-19
OREX (K940716)Thantex Specialties, Inc.1994-12-19
STERMED NON-CHLORINATED POWDER FREE GLOVES (K943839)Steriltx (Usa), Inc.1994-12-19
OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS (K944285)Osteonics Corp.1994-12-19
UNITONE (K934572)Scitex Corporation , Ltd.1994-12-15
BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (K944319)Giles Scientific, Inc.1994-12-15
HASSON OPEN LAPAROSCOPY CANNULA (K942447)Linvatec Corp.1994-12-15
RF DRIVER, RADIO FREQUENCY DRIVER (K943406)Pro-Comm, Inc.1994-12-15
INSUFFLATOR FILTER TUBING SET (K945970)Xylog Corp.1994-12-15
ADVANCE CORP. SUNGLASSES (K944235)Advance Corp.1994-12-15
SPECTACLE FRAME (K945392)Seo Han Corp., Ltd.1994-12-15
SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER (K942902)Winfield Co., Inc.1994-12-15
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC (K930536)Neuromed, Inc.1994-12-15
ATRIUM'S HYBRID PTFE (K933391)Atrium Medical Corp.1994-12-15
SPECTACLE FRAME OR EYEGLASS FRAMES (K945176)Optipia Trading Co.1994-12-15
OPTILITE V FIBEROPTIC ACCESSORIES (K944474)Xintec Corporation1994-12-15
VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED (K944221)Cryosurgery, Inc.1994-12-15
CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS (K944603)Conmedcorp1994-12-15
L-CATH CONNECTOR ASSEMBLY (K940198)Luther Medical Products, Inc.1994-12-15
GOGGLE SAFEGUARD (K944857)Sellstrom Mfg. Co.1994-12-15
STRYKER TOTAL PERFORMANCE SYSTEM (K943589)Stryker Corp.1994-12-15
VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT (K942743)Viro Research, Inc.1994-12-15
HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER (K944523)Humphrey, Inc.1994-12-15
KARL STORZ INSULATED BIOPSY FORCEPS (K944300)KARL STORZ Endoscopy-America, Inc.1994-12-15
ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT (K944845)Wrightmedicaltechnologyinc1994-12-15
ATHENA HIGH SPEED HANDPIECE (K925678)Athena Technology, Inc.1994-12-15
E.COLI 0157 LATEX TEST (K944421)Pro-Lab Diagnostics1994-12-15
PULPDENT HARDSHELL (K945173)Pulpdent Corp.1994-12-15
HOWMEDICA SENTRY S TOTAL HIP SYSTEM (K935913)Howmedica, Inc.1994-12-15
MERIT (O.1T MR SYSTEM) (K943415)Philips Medical Systems (Cleveland), Inc.1994-12-15
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 (K945238)F. Walter Hanel GmbH1994-12-15
OPTICAL FRAMES (K945770)Ramada Optics, Inc.1994-12-15
CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) (K945563)Energy Life Systems Corp.1994-12-15
KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES (K945751)KARL STORZ Endoscopy-America, Inc.1994-12-15
CARDIAC OUTPUT OPTION 39 (K943256)Medical Data Electronics1994-12-15
BONE ANCHOR (K942787)Acu Med, Inc.1994-12-15
DENTAL HYGIENE TRAY (K944139)Sterile Concepts, Inc.1994-12-15
BODILY FLUID DISPOSAL KIT (K944880)Clinical Resources, Inc.1994-12-15
HYPERGRAPH (K941162)Dermed Diagnostics, Inc.1994-12-15
ALAMAR ANTIBIOTIC SUSCEPTIBILITY (K941425)Alamar Biosciences Laboratory, Inc.1994-12-15
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (K944876)Research Diagnostics, Inc.1994-12-15
HYSTEROMAT(TM) 3700 (K921871)F.M. Wiest USA, Inc.1994-12-15
INFRARED EYE MOVEMENT MONITOR (K926312)Microguide, Inc.1994-12-15
AQUAFRESH PLAQUE FIGHTING GUM (K944575)Smithkline Beecham Consumer Healthcare Products1994-12-15
KARL STORZ INSULATED SCISSORS (K944297)KARL STORZ Endoscopy-America, Inc.1994-12-15
SUNGLASSES (K944398)Sun Island Enterprise Co., Ltd.1994-12-15
SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (K943268)Streck Laboratories, Inc.1994-12-15
GIP/MEDI-GLOBE GOREIGN BODY GRASPERS (K943476)Medi-Globe Corp.1994-12-15
MULTIPLE CO2 LAERS (K941838)Mattioli Engineering, Srl1994-12-15
PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 (K945274)Pro-Tec Containers, Inc.1994-12-14
PULPDENT HYBRID ANTERIOR COMPOSITE (K945057)Pulpdent Corp.1994-12-14
ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) (K943740)Premium Plastics, Inc.1994-12-14
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K941171)Miles, Inc.1994-12-14
ORTHODONITC METAL REINFORCED PLASTIC BRACKET (K942826)Gac Intl., Inc.1994-12-14
PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2 (K945273)Pro-Tec Containers, Inc.1994-12-14
NRF SYSTEM (K944973)Philips Medical Systems (Cleveland), Inc.1994-12-14
PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1 (K945275)Pro-Tec Containers, Inc.1994-12-14
PHILIPS BUCKY DIAGNOST FAMILY (K945278)Philips Medical Systems North America, Inc.1994-12-14
SII 525 MS (K945709)Scott Imaging Intl., Inc.1994-12-14
GLYCAR TISSUE REPAIR PATCH (K942911)Glycar, Inc.1994-12-14
HARKEN ASSURE SELF-SEAL STERILIZATION POUCH (K945055)Harken Products, Inc.1994-12-14
PULPDENT CERVICAL RESTORATIVE (K945113)Pulpdent Corp.1994-12-14
RHODIUM FILTER (K945272)Lorad Corp.1994-12-14
SII 360 MS (K945708)Scott Imaging Intl., Inc.1994-12-14
DIARLEX ROTA-ADENO (K942286)Orion Diagnostica, Inc.1994-12-14
PULPDENT RESIN CEMENT (K945056)Pulpdent Corp.1994-12-14
BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER (K942434)Bionaire Corp.1994-12-14
THE VIVACARE T.P.S. PROBE (K944848)Rms Div.1994-12-14
PULPDENT DUAL CURE UNFILLED BONDING RESIN (K945112)Pulpdent Corp.1994-12-14
PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G (K945276)Pro-Tec Containers, Inc.1994-12-14
PULPDENT MICROFILLED ANTERIOR COMPOSITE (K945058)Pulpdent Corp.1994-12-14
ADOBE C.I.C (K943016)Widex Hearing Aid Co., Inc.1994-12-14
MULTILINK SHOULDER CPM UNIT (K935587)Toronto Medical Corp.1994-12-14
MX4000 (K943794)Bfi- Medical Waste Systems1994-12-14
PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL (K945018)Pulpdent Corp.1994-12-14
AST QVET (K944102)Prisma Systems1994-12-13
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE (K944762)Puritan Bennett Corp.1994-12-13
SHIELD, EYE, OPHTHALMIC (K945351)Taiwan Eva Industrial Co., Inc.1994-12-13
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Every clearance here is in the API, with alerts when new ones post.