Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT (K862604)Puritan Bennett Corp.1986-08-01
MP-066-M RADIOAEROSOL KIT (K862793)Medipart Jerry Alexander1986-08-01
HEARING AID, UNITRON MODEL UF11 (K862760)Unitron Industries, Inc.1986-07-31
645OB SECTOR/LINEAR ULTRASOUND SCANNER (K861931)Ge Medical Systems Information Technologies1986-07-31
LUER LOCK ADAPTER/NUT (K862653)Mallinckrodt Critical Care1986-07-31
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 (K861858)Peritone Research, Ltd.1986-07-31
NIKKISO INFUSION PUMP MODEL PFA-02 (K861539)International Medical Products, Inc.1986-07-31
PRISMA METAL OPAQUERS (K862660)Dentsply Intl.1986-07-31
RIONET HEARING AID HB-35PT (K862670)Rion Acoustic Instruments, Inc.1986-07-31
BLOOD PLATELET ASSAY METHOD & APPARATUS (K862302)Bellhouse Medical, Inc.1986-07-31
BT CATH (INTRAVASCULAR CATHETER) (K862480)Baron Technologies, Inc.1986-07-31
COMET COSMIC 203/218 (K861527)Fuyo U.S.A. Co., Ltd.1986-07-31
FLUOR-ETCH GEL ETCHANT (K862695)Teledyne, Inc.1986-07-31
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY (K862667)Austenal Dental, Inc.1986-07-31
EUGENOL USP (K862745)E&D Dental Manufacturing Co.1986-07-31
MILEX KEGEL PERINEAL EXERCISER (K862410)Milex Products, Inc.1986-07-31
LAURIER SANTARY NAPKIN (MODIFICATION) (K862269)Kao Corp.1986-07-30
POLYESTER SPONGE PATTIE (K862494)American Silk Sutures, Inc.1986-07-30
JEDMED CCD CAMERA SYSTEM (K862664)Jedmed Instrument Co.1986-07-30
ACUSON L558 TRANSDUCER (K861579)Acuson Computed Sonography1986-07-30
PACEMAKER LEAD ADAPTER (K862656)Cordis Corp.1986-07-30
ACUSON S519 TRANSDUCER (K861596)Acuson Computed Sonography1986-07-30
PS SYSTEM WITH SD-200 DOPPLER (K861358)Johnson & Johnson Professionals, Inc.1986-07-30
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS (K862702)Depuy, Inc.1986-07-30
TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP (K862696)Downs Surgical , Ltd.1986-07-30
TREACE MEDICAL MICRO INSTRUMENT WIPE (K862582)Treace Medical, Inc.1986-07-30
TRACHEOSTOMY CARE TRAY (K862663)Welmed Systems, Inc.1986-07-30
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE (K860689)Spacelabs, Inc.1986-07-30
HAND MIRROR (ENDOSCOPE) (K862717)Simpson/Basye, Inc.1986-07-30
TWIN GOT-AST IFCC/GPT-ALT IFCC (K861792)Boehringer Mannheim Corp.1986-07-29
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS (K862247)V-Tech, Inc.1986-07-29
LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) (K861703)Leeco Diagnostics, Inc.1986-07-29
DANIEL ORTHO BED LIFT AC (K862738)Radco1986-07-29
KALLESTAD SSA/SSB ENA TEST REAGENTS (K862710)Kallestad Laboratories, Inc.1986-07-29
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (K862300)Amresco, Inc.1986-07-29
RIGHT-DAY URINARY LH (EIA) (K860538)Leeco Diagnostics, Inc.1986-07-29
MILLAR PULSED DOPPLER VELOCIMETER (K860766)Millar Instruments, Inc.1986-07-29
Q50 MEDICAL TREADMILL (K862741)Quinton, Inc.1986-07-29
DU PONT DRUG CALIBRATOR (K861786)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR (K862506)Millipore Corp.1986-07-29
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (K862255)Sterling Diagnostics, Inc.1986-07-29
OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40 (K862061)Coors Biomedical Co.1986-07-29
PANAVIA TC, AND PANAVIA OPAQUE (K862232)Kuraray Co.1986-07-29
IL 482 CO-OXIMETER (K862253)Instrumentation Laboratory CO1986-07-29
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS (K862262)Serono Diagnostics, Inc.1986-07-29
EMIT VALPROIC ACID ASSAY (K862652)Syva Co.1986-07-29
LIQUID CHROMATOGRAPHY COLUMNS (K862541)Supelco, Inc.1986-07-29
ANALYST ANALYTICAL TEST ROTORS (K862274)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
MVP GENERATOR, CATALOG NO. H8018 (K862682)General Electric Co.1986-07-29
STOPCOCK (K862691)Ram Development1986-07-28
MATTRESS COVER (K862380)Intera Corp.1986-07-28
LIBAN INTUBATOR (K861026)Life Support Devices Co.1986-07-28
INHALATOR MODELS 8100, 10100 AND 10200 (K862194)U.O. Equipment Co.1986-07-28
EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM (K862279)Orthospec, Inc.1986-07-25
ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS (K861733)Kyoto Diagnostics, Inc.1986-07-25
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO (K861173)Trimedyne, Inc.1986-07-25
COLLIMATOR MODEL A280BLMD & MODEL A280BLMP (K861941)D&R X-Ray Products, Inc.1986-07-25
SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (K861456)Pantheon Products, Inc.1986-07-25
STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS (K862482)Walter Lorenz Surgical, Inc.1986-07-25
BICONDYLAR TOE PROSTHESIS (K860163)Depuy, Inc.1986-07-25
COLLIMATOR MODEL A280BLE & MODEL A280-BLM (K861942)D&R X-Ray Products, Inc.1986-07-25
DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE (K861429)Siemens Gammasonics, Inc.1986-07-25
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN (K862311)Warsaw Orthopedic, Inc.1986-07-25
ACUSON S319 TRANSDUCER (K862159)Acuson Computed Sonography1986-07-24
HOWMEDICA KINEMATIC PLUS KNEE SYSTEM (K861266)Howmedica Corp.1986-07-24
ULTRASOUND IMAGING SYSTEM MODEL 280 SL (K860697)Johnson & Johnson Professionals, Inc.1986-07-24
INTELLIGRAPH(TM) PROGRAMMER (K861598)Intelligent Medicine, Inc.1986-07-24
MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT (K862335)U.S. Mfg. & Management, Inc.1986-07-24
MERIDIAN IMAGING SYSTEM (K861737)Johnson & Johnson Professionals, Inc.1986-07-24
DANNIFLEX 400SL (K862730)Danninger Medical Technology, Inc.1986-07-24
REFLEX(TM) CLIP APPLIER (K862404)Richard-Allan Medical Ind., Inc.1986-07-23
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (K862203)Mcghan Medical Corp.1986-07-23
LINEN (HUCK) TOWEL (K862577)Dimed, Intl.1986-07-23
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES (K862611)United States Surgical, A Division of Tyco Healthc1986-07-23
ELECTRO-SURGICAL PENCILS (K861742)Stryker Corp.1986-07-23
BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR (K862519)Bausch & Lomb, Inc.1986-07-23
TECHNA VISION CASTING RESIN (K862578)Techna Vision1986-07-23
CONCEPT CURETTE (K862657)Concept, Inc.1986-07-23
HYGIENIC AIR PURIFYING DEVICE (K861299)Puridyne, Inc./Imutech, Inc.1986-07-23
CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE (K862481)CIVCO Medical Instruments Co., Inc.1986-07-23
CONCEPT ARTHROSCOPIC KNIFE (K862658)Concept, Inc.1986-07-23
NIDEK KM-1000 SURGICAL KERATOMETER (K862137)Nidek, Inc.1986-07-23
CLINAGEL (ABSORBENT GEL) (K860892)Schering Chemicals, C/O Ellis Pharmaceuticals1986-07-23
CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 (K862509)Lifestream Int'L, Inc.1986-07-23
VARIOUS SURGICAL INSTRUMENTS (K862597)Konig W.G., Ltd.1986-07-23
NEMECTROSON MODEL 2 (K862376)Nemectron Medical, Inc.1986-07-23
ET/RT PAPILLOTOME (K860593)Hobbs Medical, Inc.1986-07-22
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY (K861797)Nichols Institute Diagnostics1986-07-22
MX MOBILE X-RAY SYSTEM (K862452)Philips Medical Systems (Cleveland), Inc.1986-07-22
O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER (K862015)Bipore, Inc.1986-07-22
CRITIKON 48-HOUR AIR ELIMINATING FILTER (K861644)Critikon Company, LLC1986-07-22
TRIGLYCERIDES (K862033)Pointe Scientific, Inc.,1986-07-22
ALPHA ALL-IN-THE-EAR HEARING AID (K862169)Authorized Hearing Systems, Inc.1986-07-22
TORAY FILTRYZER DIALYZER, B1-2.0. (K862693)National Medical Care, Medical Products Div., Inc.1986-07-22
PHONIC EAR PE 602 PPCS (K862229)Phonic Ear, Inc.1986-07-22
SET CANAL SEALER PASTE (K862129)Endo Technic Corp.1986-07-22
PLAYTEX TAMPONS (K861738)Intl. Playtex, Inc.1986-07-22
GINGERBREAD MAN (TM) (K862093)Southern Pride Manufacturing, Inc.1986-07-22
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) (K862590)3M Company1986-07-22
DEN-MAT DENTIN LINK (K862449)Den-Mat Corp.1986-07-22
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Every clearance here is in the API, with alerts when new ones post.