Atlas FDA

1985

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826)Roche Diagnostic Systems, Inc.1985-02-01
SEAMED MODEL 6000 (K843807)Seamed Corp.1985-02-01
DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER (K844783)Adac Laboratories1985-02-01
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE (K845026)Amersham Corp.1985-02-01
COBAS REAGENTS PHENOBARBITAL & PHENOBAR (K843825)Roche Diagnostic Systems, Inc.1985-02-01
A FAMILY OF TRACHEOBRONCHIAL SUCTION CATHETER PROD (K850032)Paco Research Corp.1985-02-01
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824)Roche Diagnostic Systems, Inc.1985-02-01
RAPID DIAGNOSTIC KIT (K844442)Portable Medical Laboratories, Inc.1985-02-01
LARIAT CATHETER (K844598)Mallinckrodt Critical Care1985-02-01
SEAMED 4000 (K843777)Seamed Corp.1985-02-01
THE MCP-70-SE SYSTEM (K844180)Ellis Pharmaceutical Consulting, Inc.1985-02-01
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC (K840037)Smec, Inc.1985-02-01
PULSE-AID DEVICE (K843977)James J. Lally1985-02-01
CARDIAC COMPUTER SP1445 (K843555)Gould, Inc.1985-02-01
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827)Roche Diagnostic Systems, Inc.1985-02-01
VARIABLE PRIME COBE MEMBRANE LUNG (K842908)Cobe Laboratories, Inc.1985-02-01
SOPHEIA/MP CORTISOL EIA KIT (K850008)Diagnostic Products Corp.1985-02-01
SPACELABS SERIES 600 PATIENT MONITORS (K844888)Spacelabs, Inc.1985-02-01
DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER (K844784)Adac Laboratories1985-02-01
ECONO MATE -OXYGEN CONCENTRATOR (K850253)Mountain Medical Equipment, Inc.1985-02-01
COLOR DOPPLER 880 (K843643)Irex Corp.1985-01-31
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (K844558)Universal Medical Instrument Corp.1985-01-31
TITANIUM MITTELMEIER TYPE ACETABULAR (K842466)American Ortomed Corp.1985-01-30
MEDSENTRY SOFTOUCH SYSTEM (K844499)Medsentry Corp.1985-01-30
TITERTEK DULUTER/DISPENSER 78-640-00 (K844568)Flow Laboratories, Inc.1985-01-30
UNILOC-CEMENTLESS & SELF TAP ACETABULAR (K842518)American Ortomed Corp.1985-01-30
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (K844571)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-30
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS (K844634)Precision Dynamics Corp.1985-01-30
BIO-STAT III PLATE WASHER (K844552)Whittaker Bioproducts, Inc.1985-01-30
POLYSTAT, BIOLOGICAL STAIN (K844640)Surgipath Medical Industries, Inc.1985-01-30
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE (K850110)Abbott Laboratories1985-01-29
JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR (K844093)Jcm Labs, Inc.1985-01-29
WETS & DRIES (K844832)Abco Dealers, Inc.1985-01-29
CMV TEST (K843138)Microbiological Research Corp.1985-01-29
ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (K842039)Argon Medical Corp.1985-01-29
CULTURESET HSV ISOLATION & ID SYS (K842216)Ortho Diagnostic Systems, Inc.1985-01-29
PERRY SUTURING SET W/ANESTHETIC (K844610)Perry, Div.1985-01-29
KINAIR, LOW AIR LOSS BED (K843781)Kinetic Concepts, Inc.1985-01-28
MODEL 1001 (K844718)A0kfusion Systems, Inc.1985-01-28
360 INFUSER (K844719)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-28
STRATOFUSE SYRINGE PIGGYBACK PUMP (K844627)Strato Medical Corp.1985-01-28
FLOW MED SK 140 BURET (K844820)D.R.O. Medical, Inc.1985-01-28
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE (K844730)C.R. Bard, Inc.1985-01-28
GRC-WT, GRC-W (K843899)Olympus Corp.1985-01-28
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (K845023)Storz Instrument Co.1985-01-28
SYSTE MATE IRON, HEM NO. 67224 (K845020)Em Diagnostic Systems, Inc.1985-01-28
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI (K844937)Y1985-01-25
ABBOTT LIFECARE 500 INFUSER (K844768)Abbott Laboratories1985-01-25
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP (K844879)Huntleigh Technology, Inc.1985-01-25
ELEX ELECTRONIC DIGITAL THERMOMETER (K843609)Ewing Intl. , Ltd.1985-01-25
THE BIBICURE SYS BREAST TONER (K843544)Les Entreprises Bibi, Inc.1985-01-25
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (K844407)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-25
K.M. PRODUCTS ASPIRATOR (K844200)Km Products1985-01-25
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES (K844880)Huntleigh Technology, Inc.1985-01-25
ABBOTT LIFECARE 900 VOLUMETRIC PUMP (K844091)Abbott Laboratories1985-01-25
TRANSDUCER 4.OMHZ LA4011 (K841048)Philips Ultrasound, Inc.1985-01-25
GORE-TEX TUNNELER (K844584)W. L. Gore & Associates, Inc.1985-01-24
AIRES TUOHY NEEDLES 17GA. X 4 1/2 (K850111)Aries Medical, Inc.1985-01-24
INTERCEPTOR, 662-01 (K844279)Intermedics, Inc.1985-01-24
PDS POLYDIOXANONE MESH (K844228)ETHICON, Inc.1985-01-24
SUNDT-KEES REINFORCING ANEURYSM CLIP (K844352)Kees Surgical Specialty Co., Inc.1985-01-24
AIRCO NITROUS OXIDE REGULATOR (K850106)Airco, Inc.1985-01-24
PACE AID MODEL 53 (K844811)Cardiac Resucitator Corp.1985-01-24
CARDIOVIT CV-3 (K841254)Schiller AG1985-01-24
OMNIMED NASAL OXYGEN CANNULA (K850066)Omni Intl., Inc.1985-01-24
TOWEL PACK, SURGICAL (K850016)East Texas Lighthouse For the Blind1985-01-23
IMSI/METRIPOND GRIPPER PLATE (K843370)Intl. Management Services, Inc.1985-01-23
ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS (K844120)Echo Ultrasound1985-01-23
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS (K844415)Depuy, Inc.1985-01-23
IN THE EAR MODEL X-ITE 84 (K844985)Bernafon, Inc.1985-01-23
ADVANCED HEARING INSTRUMENTS - HEARING AIDS (K844728)Advanced Hearing Instruments1985-01-23
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER (K844836)Edward Weck, Inc.1985-01-23
HEARING AID, UNITRON UE12-PPL (K843246)Unitron Industries, Inc.1985-01-23
EMIT PHENYTOIN ASSAY (K844991)Syva Co.1985-01-23
ELECTRO-NERVE STIMULATOR B5/SK700B (K844076)Biomedical Life Systems, Inc.1985-01-23
FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT (K844347)Fisher Diagnostics1985-01-23
CARDIO IV/GXT STRESS TESTING SYSTEM (K844744)Intl. Medical, Inc.1985-01-23
ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (K844247)Technicare Corp.1985-01-23
HIGH RESOLUTION 5 MHZ LINEAR ARRAY (K844449)Siemens Medical Solutions USA, Inc.1985-01-23
DR. HESSEL'S INSECT POISON REMOVER (K844048)Medie Group1985-01-23
SKIN STAT II SKIN STAPLING MEDICAL DEVICE (K844838)Edward Weck, Inc.1985-01-23
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (K843969)Gould, Inc.1985-01-23
BIOBRANE BRAND TEMP. WOUND DRESSING W/ADHESIVE (K844052)Woodroof Laboratories, Inc.1985-01-23
PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS (K844176)Premie Comfort Products1985-01-23
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE (K850014)Medi-Dent American, Inc.1985-01-23
VISISTAT SKIN STAPLING DEVICE (K844837)Edward Weck, Inc.1985-01-23
MEDO BUBBLE BATH MA-80, 400, 600 & 700 (K844064)Medo U.S.A., Inc.1985-01-23
STORZ CORNEO-SCAN II CS2000 (K844477)Storz Instrument Co.1985-01-23
OSADA ENAC (K844250)Osada Electric Co., Ltd.1985-01-23
HOLDSTER ARM RETENTION SYSTEM (K844157)P.G.L. Medical1985-01-23
MECON X (TEN) (K843484)Mecon Labs1985-01-23
MX2 ELECTRONIC STETHOSCOPE (K842705)Medmax, Inc.1985-01-23
CIVCO SCAN DRAPE (K844472)CIVCO Medical Instruments Co., Inc.1985-01-23
SONOCARE (K844034)Echo Ultrasound1985-01-23
SYVA ADVANCE EMIT PHENYTOIN ASSAY (K844990)Syva Co.1985-01-23
DR-2C (K844650)General Devices1985-01-22
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY (K844715)Optical Micro Systems, Inc.1985-01-22
NEPHROSS ALLEGRO H.F. (K844748)Organon Teknika Corp.1985-01-22
TITERTEK MICROPLATE WASHER 120 (K844500)Flow Laboratories, Inc.1985-01-22
TITMUS VISION TESTER II (K844694)Titmus Optical, Inc.1985-01-22
← Previous Next →

Track 1985 automatically

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