Atlas FDA

1985

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

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RecordFirmDate
HEALTHDYNE IMPLUSE VENTILATOR (K853300)Healthdyne, Inc.1985-08-15
FEMTEST (K844173)Bionexus, Inc.1985-08-14
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A (K852827)Cordis Corp.1985-08-14
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY (K851000)Cooper Lasersonics, Inc.1985-08-14
TECA TC2-64 TRANSCRANIAL DOPPLER (K850137)Teca, Inc.1985-08-14
SONORANGER (K852549)Ausonics Pty , Ltd.1985-08-14
KITECKO ULTRASOUND STANDOFF PAD (K851982)3M Company1985-08-14
GASTRO-ENTEROSTOMY TUBE (K852707)Medical Innovations Corp.1985-08-14
PIGGYMATE I.V. TUBING LOCK (K853184)Trend Medical, Inc.1985-08-13
BELIEVE DEODORANT LABIAL PADS (K852225)Kimberly-Clark Corp.1985-08-13
SIERRA -OXYGEN CONCENTRATE (K852144)Mountain Medical Equipment, Inc.1985-08-13
BRANDT TRACHEAL TUBE(TENTATIVE) (K852025)Mallinckrodt Critical Care1985-08-13
GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843)Warner-Lambert Co.1985-08-13
COAGULATOR (K852492)Med USA1985-08-13
AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (K853081)Advanced Medical Technology, Inc.1985-08-13
S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (K853005)The S. S. White Co.1985-08-13
OXYMATICTM ELECTRONIC OXGYEN CONSERVER (K852650)Chad Therapeutics, Inc.1985-08-13
THE FEVER-THERM A THERM. MEASURING DEVICE (K850395)Kma, Inc.1985-08-13
ECUMOL ULTRAVIOLET SUNTANNNING BEDS (K853177)Mottek Intl. Corp.1985-08-13
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (K852665)Syncor Intl. Corp.1985-08-13
ENDOPORT 5MM (K852031)Endotherapeutics1985-08-13
#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT (K852314)Sigma Medical, Inc.1985-08-13
ACRIDINE ORANGE FLUORESCENT STAIN (K853187)Advanced Medical Technology, Inc.1985-08-13
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS (K852705)Waldemar Link GmbH & Co. KG1985-08-13
CALCIUM CHLORIDE (K853246)Bio/Data Corp.1985-08-13
URINE DUO (K851225)Culture Kits, Inc.1985-08-13
DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE (K852519)E.I. Dupont DE Nemours & Co., Inc.1985-08-12
ENDAB PHENOBARBITAL (K852995)Immunotech Corp.1985-08-12
DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR (K852176)E.I. Dupont DE Nemours & Co., Inc.1985-08-12
PLASTINEX (K852484)Bio/Data Corp.1985-08-12
MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK (K852604)Clairol, Inc.1985-08-12
MALIS BIPOLAR PEN (K853168)Valley Forge Scientific Corp.1985-08-12
ULTRACLONE ECL-01-2200 CELL LINE (K853203)Earl-Clay Laboratories, Inc.1985-08-12
EFFNER-EYE CAUTERY WITH BATTERY HANDLE (K844775)Mecron Medical Products, Inc.1985-08-12
VECTOR BAR SUSPENSION/TRACTION UNIT (K852398)Powlan Manufacturing Co.1985-08-12
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE (K853244)Simmler, Inc.1985-08-12
TD TRICYCLIC ANTIDEPRESSANTS (K853113)Abbott Laboratories1985-08-12
HOT PACK (K852610)Oriental Medical Supplies, Inc.1985-08-12
VISIDEX II REAGENT STRIPS (K852747)Miles Laboratories, Inc.1985-08-12
CITREX II (K853077)Bio/Data Corp.1985-08-12
CITREX I (K853076)Bio/Data Corp.1985-08-12
HUMPHREY IMAGE ANALYZER MODEL 110 (K852638)Zeiss Humphrey System1985-08-12
CEPHALINEX ACTIVATED PTT REAGENT (K852195)Bio/Data Corp.1985-08-12
T-3 RIASSAY (K852537)Ria Diagnostics1985-08-12
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU (K851323)C.R. Bard, Inc.1985-08-12
OCULAR PRESSURE REDUCER (MCCANNEL) (K852032)Visitec Co.1985-08-12
TRIGLYCERIDES LCK 124 (K853041)German American Chamber of Commerce, Inc.1985-08-12
ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 (K852683)American Bentley1985-08-12
METALLIC SUNGLASSES (K852902)Yours Enterprise Co., Ltd.1985-08-12
VISION POTASSIUM (K850950)Abbott Laboratories1985-08-12
CEFTAZIDIME 30 MCG SENSITVITY DISCS (K852835)Difco Laboratories, Inc.1985-08-12
HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER (K852449)Howmedica Corp.1985-08-12
CITREX III (K853078)Bio/Data Corp.1985-08-12
CAPIOX BLOOD SAMPLING MANIFOLD (K852086)Terumo Medical Corp.1985-08-09
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD (K851897)Cardiac Control Systems, Inc.1985-08-09
BARD-PARKER IRRIGATION CATHETER (K852099)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-08-09
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (K852956)Parker Laboratories, Inc.1985-08-09
PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (K852232)Dlp, Inc.1985-08-09
KIRSCHNER SELF-TAPPING ACETABULAR CUP (K852351)Kirschner Medical Corp.1985-08-09
MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE (K852679)J. & Jp., Inc.1985-08-09
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT (K852363)Medical Innovations Corp.1985-08-09
VISITEC 2 MICRON FLUID FILTER (K853135)Visitec Co.1985-08-09
BELIEVE LABIAL PADS (K852226)Kimberly-Clark Corp.1985-08-09
TOTAL CPM (K852399)Invacare Corp.1985-08-09
CO2 FOR ARTHROSCOPY (K852592)The Anspach Effort, Inc.1985-08-09
RADI-BIOPSY DEVICE (K850605)Radiplast AB1985-08-09
FOAM ECG ELECTRODES (K852177)Clinical Data, Inc.1985-08-09
SPECTACLE PRESCRIPTION LENSES (K853110)Ancie Laboratories1985-08-09
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 (K852271)CooperVision, Inc.1985-08-09
MECTA ECT DEVICE MODELS SR & JR (K852069)Mecta Corp.1985-08-09
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) (K852397)Howmedica Corp.1985-08-09
PULMONARY VEIN CLAMP (K852479)None1985-08-09
URETERAL DILATOR/SHEATH SET (K852793)American Edwards Laboratories1985-08-09
PROTECTIVE PAD FOR INCONTINENCE (K853079)I.C.D. Industries, Inc.1985-08-09
UNI-PLATE (K852643)Medical Specialties Laboratories1985-08-08
SUNNY SUN MAGNIFYING GLASSES (K852830)Sunny Optical Co., Ltd.1985-08-08
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET (K852287)Cook Ob/Gyn1985-08-08
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW (K852792)Corpak Co.1985-08-08
OR TUBE RESTRAINT (K851874)Kinetic Concepts, Inc.1985-08-08
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L (K852834)Ortho Diagnostic Systems, Inc.1985-08-08
CHLAMYDIA (K843654)Institute Virion , Ltd.1985-08-08
AMSCO URO-ENDO MOBILE TABLE (K852127)American Sterilizer Co.1985-08-08
MAYFIELD DISPOSABLE SKULL PINS (K853066)Codman & Shurtleff, Inc.1985-08-08
Q-FEVER (K843672)Institute Virion , Ltd.1985-08-08
SUNGLASSES (K852773)Pony Industries Co., Ltd.1985-08-08
PFEIFFER PUMP (K851525)Ing. Erich Pfeiffer GmbH & Co. Kg.1985-08-08
PRECISION - COSMET CAPSULE COUPEUR (K852934)Precision-Cosmet Co., Inc.1985-08-08
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE (K851813)Victoreen, Inc.1985-08-07
SHARPLAN MODEL 1060 CO/2 SURGICAL LASER (K850633)Laser Industries , Ltd.1985-08-07
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI (K852948)Amresco, Inc.1985-08-07
DONWAY LIFTING FRAME (K851660)Australian Biomedical Corporation , Ltd.1985-08-07
GENESYS GAMMA COUNTER (K851689)Laboratory Technologies, Inc.1985-08-07
UROBEI STRESS INCONTINENCE MONITOR (K851483)Browne Medical, Inc.1985-08-07
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM (K852353)Thomson-Cgr Medical Corp.1985-08-07
BONE RONGEURS (K852993)The Huxley Instrument Corp.1985-08-07
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA (K852014)Effner and Spreine Co.1985-08-07
ESTEEM INCONTINENT SYSTEM (K852276)Bevan Medical, Inc.1985-08-07
SUNBIRD (POWERED WHEELCHAIR) (K852379)Venturego, Inc.1985-08-07
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG (K852085)The Kendal Co.1985-08-07
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (K853010)Roche Diagnostic Systems, Inc.1985-08-07
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Track 1985 automatically

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