Atlas FDA

1985

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

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RecordFirmDate
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (K850107)Nicolet Biomedical Instruments1985-04-11
BRAIN FUNCTION MAPPING OPTION FOR PATHF (K843598)Nicolet Biomedical Instruments1985-04-11
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG (K850108)Nicolet Biomedical Instruments1985-04-11
CARDIOSTAT 1 ECG RECORDER (K844392)Siemens Elema AB1985-04-11
VIGGO SECALON T CATHETER (K850460)Viggo Products1985-04-11
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK (K850280)Viggo Products1985-04-11
BLOOD GAS SAMPLER KIT (K850958)Churchill Corp.1985-04-10
PORTABLE DEFIBRILLATOR/MONITOR ED 425 (K851092)Honeywell, Inc.1985-04-10
F-SERIES IMPLANT (K850706)Omni Intl., Inc.1985-04-10
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A (K844791)Analogic Corp.1985-04-10
Q-DOP (K843058)Quinton, Inc.1985-04-10
IR-192 IMPLANT (K844248)Rads S.L., Inc.1985-04-10
DENTAL MASSAGING PICKS (K850775)L.A.K. Ent., Inc.1985-04-10
MOBILE LEAD PLASTIC X-RAY BARRIERS (K850813)Victoreen, Inc.1985-04-10
GLAS IONOMER CEMENT (K850913)Shofu Dental Corp.1985-04-10
IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET (K851297)Telectronics, Inc.1985-04-10
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (K850820)Universal Medical Instrument Corp.1985-04-10
RABBIT-PERSONAL COMPUTER FOR WOMEN (K845009)Sanimor, Inc.1985-04-10
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT (K851104)Amersham Corp.1985-04-10
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR (K850622)Oscor Medical Corp.1985-04-10
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 (K851079)Beckman Instruments, Inc.1985-04-10
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER (K850948)D&R X-Ray Products, Inc.1985-04-10
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER (K850760)Scimed Life Systems, Inc.1985-04-10
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT (K850075)Scimed Life Systems, Inc.1985-04-10
GL ULTRASOUND SECTOR 170 (K844393)Gl Ultrasound , Ltd.1985-04-10
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H (K850575)American Dade1985-04-10
ELECATH TORKFLOAT PACING PROBE (K850065)Electro-Catheter Corp.1985-04-10
CARDIAC SECTOR PROBE 5.0 MHZ (K850216)Siemens Medical Solutions USA, Inc.1985-04-10
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH (K851295)Telectronics, Inc.1985-04-10
CARDIAC SECTOR PROBE 3.5. MHZ (K850145)Siemens Medical Solutions USA, Inc.1985-04-10
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD (K850652)Pacesetter Systems1985-04-10
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH (K851294)Telectronics, Inc.1985-04-10
BASICAM COUNTER BALANCE CAMERA (K850463)Siemens Gammasonics, Inc.1985-04-10
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES (K850897)Fukuda Denshi USA, Inc.1985-04-10
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER (K850139)Rapid Diagnostic Laboratories, Inc.1985-04-10
CORONARY INFUSION CATHETER W/SIDEHOLES (K850353)Advanced Cardiovascular Systems, Inc.1985-04-10
MODULAR X-RAY BARRIERS (K850814)Victoreen, Inc.1985-04-10
HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR (K851011)Hofmann X-Ray of America, Inc.1985-04-10
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR (K850823)Philips Medical Systems (Cleveland), Inc.1985-04-10
DIAGNOSTIC ULTRASOUND 105 & 110 (K842539)Diagnostic Ultrasound Corp.1985-04-10
LEAD PLASTIC VIEWING PANELS (K850816)Victoreen, Inc.1985-04-10
PROMINJECT PROGRAMMABLE INFUSION PUMP (K850669)Pharmacia, Inc.1985-04-09
VASCULON I.V. CANNULAE (K850278)Viggo Products1985-04-09
EQUIPMENT SNAP KOVERS (K850959)Advance Medical Designs, Inc.1985-04-09
DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (K850132)Consolidated Medical Equipment, Inc.1985-04-09
CARDIO-NEC MODEL 365 (K844101)Birtcher Corp.1985-04-09
AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR (K850825)Pall Biomedical Products Co.1985-04-09
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 (K850826)Pall Biomedical Products Co.1985-04-09
XMA INTEGRATED TABLE (K850118)Summit Industries, Inc.1985-04-09
XMA 325 (X-RAY GENERATOR) (K850117)Summit Industries, Inc.1985-04-09
OMNI PHASE PENILE PROSTHESIS (K850019)Dacomed Corp.1985-04-09
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR (K850167)Urologics, Inc.1985-04-09
VIGGO ARTERIAL CANNULA (K850349)Viggo Products1985-04-09
URETERAL DILATION SET (K851144)Van-Tec, Inc.1985-04-09
MASTER KIT A (K850246)Pro-Lab, Inc.1985-04-09
BOSCH IN THE EAR HEARING AID SUPERSTAR (K850188)Robert Bosch Corp.1985-04-09
GAMBRO PRESSURE MONITOR GUARDS (K851230)Gambro, Inc.1985-04-09
ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 (K850729)Surgidev Corp.1985-04-09
MODEL 78231D CARDIAC OUTPUT MODULE (K850568)Hewlett-Packard Co.1985-04-09
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE (K850365)Eaton Medical Group1985-04-09
IVAC DRUG ADMINISTRATION DEVICE (K844843)Y1985-04-09
CORMED II AMBULATORY INFUSION PUMP (K850674)Cormed, Inc., Sub. C.R.Bard, Inc.1985-04-09
PRN ECG ELECTRODE (K850130)Consolidated Medical Equipment, Inc.1985-04-09
IMED 440 INFUSION PUMP & ADMINISTRATION SET (K850653)Imed Corp.1985-04-09
IAI PROGRAM-COMPUTER PROGRAM (K844997)Intl. Acoustics, Inc.1985-04-09
ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM (K850509)Laser Media1985-04-08
CERESTORE DENTIN PORCELAIN (K850821)Johnson & Johnson Professionals, Inc.1985-04-08
PRECO PREGNANCY RAPID CARD TEST, HEM #2028 (K850604)Preco, Inc.1985-04-08
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES (K850256)Abbott Laboratories1985-04-08
PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST (K850824)Kuraray Co.1985-04-08
LUNE AU CURETTES (K850068)Luneau Laboratories1985-04-08
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN (K850999)Technicon Instruments Corp.1985-04-08
DATA ZYME CO2 PROCEDURE (K850903)Data Medical Associates, Inc.1985-04-08
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE (K850728)Cooper Lasersonics, Inc.1985-04-08
MICROSURGERY VISIBILITY BACKGROUND MATERIAL (K850375)ETHICON, Inc.1985-04-08
BIOMEDICS BLADDER SCANNER (K842687)Biomedics1985-04-08
COMPACT EXCHANGE DEVICE 5C4197 (K851208)Travenol Laboratories, S.A.1985-04-08
SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR (K850013)Mettler Electronics Corp.1985-04-08
KORVIN VITA RADIOPAQUE PLASTIC TEETH (K844670)Credent Co.1985-04-08
ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN (K844765)Laser Spectrum, Inc.1985-04-08
POST-AURICULAR HEARING AID MODEL PE 600PPCH (K844862)Phonic Ear, Inc.1985-04-08
GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. (K851110)The Huxley Instrument Corp.1985-04-08
STREP A QUICK (K850831)Abbott Laboratories1985-04-08
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM (K850987)Medix Biotech, Inc.1985-04-08
BACI 6 -ADRENOCORTICOTROOP HORMONE (K850053)Euro-Diagnostics BV1985-04-08
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 (K851207)Travenol Laboratories, S.A.1985-04-08
MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (K844597)Xanmed Corp.1985-04-08
AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE (K850265)American Pharmaseal Div. Ahsc1985-04-05
AUDIT TM V (K843712)Axonics, Inc.1985-04-05
EMIT QST N-ACETYLPROCAINAMIDE ASSAY (K851060)Syva Co.1985-04-05
TEMPALERT LIQUID CRYSTAL THERMOMETER (K850797)Medical Frontiers, Inc.1985-04-05
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT (K850181)Aequitron Medical, Inc.1985-04-05
CYBERTENS (K844680)Pori Associates, Inc.1985-04-05
HAND HELD GONIOMETER (K850082)Chattanooga Group, Inc.1985-04-04
TREADMILL E-17 (K850044)Del Mar Avionics1985-04-04
COMPARTMENT SYNDROME PRESSURE MONITOR SYS (K844214)Stryker Corp.1985-04-04
TANDEM SETS I.V. (K850757)Acacia, Inc.1985-04-04
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II (K851081)Telectronics, Inc.1985-04-04
NORELCO DIGITAL MODEL 987 THERMOMETER (K851010)Philips Park1985-04-04
MEDITECH EUROSCANNER M250 (K850027)Stuart Medical, Inc.1985-04-04
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Every clearance here is in the API, with alerts when new ones post.