Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LETOURNEL ACETABULAR PLATE (K850401)Pfizer, Inc.1985-04-19
NUMED BALLOON PACING CATHETER (K851246)NuMED, Inc.1985-04-19
MEDICAL, DISPOSABLE BEDDING (K850067)East Texas Lighthouse For the Blind1985-04-19
CERYX6, 611, CERYX 3 311 & CERYX 1 111 (K844485)Vitatron Medical BV1985-04-19
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE (K850623)Oscor Medical Corp.1985-04-19
PHENYLALANINE AGAR (K851346)Micro Media Laboratories1985-04-19
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER (K851078)Hdc Corp.1985-04-19
PURPLE BROTH (K851345)Micro Media Laboratories1985-04-19
COMPRESSION HIP SCREW SYSTEM (K850886)Pfizer, Inc.1985-04-19
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD (K851145)Pacesetter Systems1985-04-19
FISHER DIAGNOSTICS LATEST-CRP TEST KIT (K850160)Fisher Diagnostics1985-04-19
VARICELLA-ZOSTER(IGG) IFA TEST (K841434)Zeus Scientific, Inc.1985-04-19
MEC INTRAMEDULLARY ROD (K850441)Pfizer, Inc.1985-04-19
TP 1 (K844483)Vitatron Medical BV1985-04-19
FC-700 DEFIBRILLATOR (K850618)Fukuda Denshi USA, Inc.1985-04-19
AUSONICS 150 (K843971)Ausonics Pty , Ltd.1985-04-18
ND2100 SPINE SCANNER (K844835)Nuclear Data, Inc.1985-04-18
COPAL DIGITAL SPHYGMOMAMOMETER UA-550 (K844285)Takeda Medical, Inc.1985-04-18
PATIENT MONITOR MODEL RM-300 (K850794)Honeywell, Inc.1985-04-18
NEOS-LP PULSE GENERATOR (K844842)Biotronik Sales, Inc.1985-04-18
NEOS-M PULSE GENERATOR (K844795)Biotronik Sales, Inc.1985-04-18
DISPLAY MONITOR (VD-711RA-VD-712RA) (K850343)Nihon Kohden America, Inc.1985-04-18
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 (K844397)Associated Mills, Inc.1985-04-18
UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050 (K850318)Nihon Seimitsu Sokki Co., Ltd.1985-04-18
NEOS - PULSE GENERATOR (K844812)Biotronik Sales, Inc.1985-04-18
SUN BEDS (K851255)Tannhut1985-04-18
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (K844396)Associated Mills, Inc.1985-04-18
BLOOD-PRESSURE ECG TRANSMITTER (K844310)Instromedix, Inc.1985-04-18
TELEMANOMETER (K850166)R.J. Ash, Medical Monitoring, Inc.1985-04-18
LEPTOS PULSE GENERATOR (K844794)Biotronik Sales, Inc.1985-04-18
NEONATAL MONITOR 309 (K850407)Rigel Medical Electronics, Inc.1985-04-18
KALOS-04 PULSE GENERATOR (K844841)Biotronik Sales, Inc.1985-04-18
AUSONICS 357 (K843994)Ausonics Pty , Ltd.1985-04-18
ULTRASOUND GEL (K850290)Litton Datamedix1985-04-18
CORNEOMAP 4500 (K844299)Radionics Medical, Inc.1985-04-18
AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL (K850678)Fairchild Medical Systems, Inc.1985-04-18
SINGLE LEG MAYFIELD TABLE (K851022)Ohio Medical Instrument Co., Inc.1985-04-17
ALBA DRY BURN DRESSING (K850904)Alba Health Care1985-04-17
SILICONE SPLINTING MATERIAL (K840113)General Dental Products, Inc.1985-04-17
ALBA DRY BURN PAD (K850881)Alba Health Care1985-04-17
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 (K851278)Stanbio Laboratory1985-04-17
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS (K850360)Text Tech Corp.1985-04-17
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE (K850560)Precision Medical, Inc.1985-04-17
ARROW-GEISS PERCUTANEOUS TPN KIT (K844080)Arrow Intl., Inc.1985-04-17
H-H TENDEON IMPLANT (K843013)Holter-Hausner Intl.1985-04-17
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S (K851308)Technicon Instruments Corp.1985-04-17
ETHICON - CHOLANGIOCLIP (K850273)ETHICON, Inc.1985-04-17
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS (K850947)American V. Mueller1985-04-17
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT (K850173)Ausonics Pty , Ltd.1985-04-16
ND1100 BONE DENSITY SCANNER (K844766)Nuclear Data, Inc.1985-04-16
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 (K850316)Nihon Seimitsu Sokki Co., Ltd.1985-04-16
ELEKIBAN MAGNETO-THERAPEUTIC DEVICE (K850172)Mns, Ltd.1985-04-16
BOVO MOISTURE GUARD (K850988)E.H. Medical Co.1985-04-16
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050 (K850317)Nihon Seimitsu Sokki Co., Ltd.1985-04-16
HEAD-SPINE STABILIZER HSS-1 (K844926)Imaging Accessories, Inc.1985-04-16
ULTRAFIL-LT (GUTTA PERCHA) (K850863)The Hygenic Corp.1985-04-16
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR (K851091)Medtronic Vascular1985-04-16
TRIAD C & B MATERIAL (K850911)Dentsply Intl.1985-04-16
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050 (K850315)Nihon Seimitsu Sokki Co., Ltd.1985-04-16
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS (K843708)Adac Laboratories1985-04-16
BIOLOGICAL TELEMETRY SYSTEM (K850087)Chattanooga Group, Inc.1985-04-16
WAX BITE IMPRESSION WAFER (K850915)Toothprints, Inc.1985-04-16
VAN-TEC MEATAL DILATOR (K851158)Van-Tec, Inc.1985-04-15
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA (K850149)CooperVision, Inc.1985-04-15
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE (K850046)Professional Supplies, Inc.1985-04-15
AMBU CPAP SYSTEM (K851194)Ambu, Inc.1985-04-15
KCP PAK #2 CONVENIENCE PACK MODIFICATION (K850275)CooperVision, Inc.1985-04-15
AMNIGLOVE & AMNICOT (K850758)Go Medical Industries Pty. , Ltd.1985-04-15
SPARCO SCOPE GUARD (K850268)Sparco, Inc.1985-04-15
HENNING MENISCAL SUTURE KIT (K843942)Stryker Corp.1985-04-15
KCP PAK CONVENIENCE PACK (K850148)CooperVision, Inc.1985-04-15
PLUS 1 (K850478)Dymax Corp1985-04-15
ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK (K850532)Atlantic Optical Systems, Inc.1985-04-15
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER (K851162)Van-Tec, Inc.1985-04-15
WOUND DRESSING MODEL ZB-6 (K850076)Thermedics, Inc.1985-04-15
HFF GENCELLS (K850990)Bioassay Systems Research Corp.1985-04-12
TOTAL HIGE ENZYME IMMUNOASSAY (K850786)Nms Pharmaceuticals, Inc.1985-04-12
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS (K850392)Clinical Data, Inc.1985-04-12
TACTILE PLUS DENTAL ELEVATORS (K850906)Ipco Corp.1985-04-12
PACKETS FOR PREP. OF DIALYSATES & INFUSATES - (K851188)Organon Teknika Corp.1985-04-12
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS (K850296)Behring Diagnostics, Inc.1985-04-12
CURING LIGHT (K843049)Penn-Med Technology, Inc.1985-04-12
BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET (K851101)Bionomy, Inc.1985-04-12
HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2 (K851379)Healthcheck Corp.1985-04-12
VIGGO NEOFLON INFUSION CANNULA (K850276)Viggo Products1985-04-12
MAST LUMINESCENT ALLERGY SYSTEM (K844629)Mast Immunosystems1985-04-12
EMIT QST PROCAINAMIDE ASSAY (K851061)Syva Co.1985-04-12
MAST ALLERGY SYSTEM (K843694)Mast Immunosystems1985-04-12
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES (K851089)Sherwood Medical Co.1985-04-12
PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS (K851356)Intl. Playtex, Inc.1985-04-12
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE (K851090)Sherwood Medical Co.1985-04-12
PHARMACIA INSULIN RIA (K851071)Pharmacia, Inc.1985-04-12
PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS (K851355)Intl. Playtex, Inc.1985-04-12
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO (K850574)American Dade1985-04-12
VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC. (K850277)Viggo Products1985-04-12
MEDIX VISUAL URINE HCG (7/7) TEST (K850949)Medix Biotech, Inc.1985-04-12
SIEMENS SIRECUST 404N NEONATAL MONITOR (K844187)Siemens Medical Solutions USA, Inc.1985-04-11
AIRVIT MODEL 8500 (K843594)Lasermed Corp.1985-04-11
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH (K851296)Telectronics, Inc.1985-04-11
ELECTROENCEPHALOGRAPH EEG (K850259)Nicolet Biomedical Instruments1985-04-11
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Track 1985 automatically

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