Atlas FDA

1986

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

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RecordFirmDate
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 (K862349)Em Diagnostic Systems, Inc.1986-07-07
EPICATH (K862358)Hdc Corp.1986-07-07
THE D & C PAD-SAC (K862297)Nu-Gyn-Tek, Inc.1986-07-07
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR (K855232)Neuroscience, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, ARGININE (K862396)Otisville Biotech, Inc.1986-07-03
MONO-LATEX (TM) SLIDE TEST (K862008)Armkel, LLC1986-07-03
BIOTIS BORDET GENGOU AGAR (K862390)Otisville Biotech, Inc.1986-07-03
PERENNIAL RYE ALLERGEN DISC (K862173)Immuno Nuclear Corp.1986-07-03
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER) (K861228)General Electric Co.1986-07-03
BIOTIS ACETAMIDE AGAR (K862389)Otisville Biotech, Inc.1986-07-03
CONCORD CARE TRAY (K862039)Concord Laboratories, Inc.1986-07-03
BIOTIS SXT AGAR (K862399)Otisville Biotech, Inc.1986-07-03
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD (K862052)Intermedics, Inc.1986-07-03
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY (K862417)Austenal Dental, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, BASE (K862395)Otisville Biotech, Inc.1986-07-03
ENGLISH PLAINTAIN ALLERGEN DISC (K862264)Immuno Nuclear Corp.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (K862398)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, LYSINE (K862397)Otisville Biotech, Inc.1986-07-03
AMPLIFIED ELISA IGE KIT (K862368)Allertec, Inc.1986-07-03
BIOTIS KV LAKED BLOOD AGAR (K862400)Otisville Biotech, Inc.1986-07-03
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (K860472)Nuclear Diagnostics, Inc.1986-07-03
COMBISON R 320A (K861376)Cone Instruments, Inc.1986-07-03
EMPI MODEL 720 NMS, TENS (K861451)Empi1986-07-03
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM (K860574)Gen-Probe, Inc.1986-07-03
MULTI-DAY ELECTRODES (K862011)Medical Electronic Assn.1986-07-03
BIOTIS LITMUS MILK (K862393)Otisville Biotech, Inc.1986-07-03
BIOTIS MITIS SALIVARIUS (K862394)Otisville Biotech, Inc.1986-07-03
BIOTIS TCBS AGAR (K862388)Otisville Biotech, Inc.1986-07-03
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (K862387)Otisville Biotech, Inc.1986-07-03
BIOTIS DESOXYCHOLATE AGAR (K862391)Otisville Biotech, Inc.1986-07-03
BIOTIS MOTILITY TEST MEDIUM (K862392)Otisville Biotech, Inc.1986-07-03
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (K862083)Hygeia Sciences1986-07-02
SINGLE-USE PATIENT UNDERPAD (K862348)Procter & Gamble Mfg. Co.1986-07-02
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER (K861303)Miles Laboratories, Inc.1986-07-02
CLINIFACTS 200 DATA MANAGEMENT SYSTEM (K861778)Miles Laboratories, Inc.1986-07-02
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (K862425)Gibco Laboratories Life Technologies, Inc.1986-07-02
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM (K860782)Gen-Probe, Inc.1986-07-02
ANTI-LEU-12 B CELL REAGENT (K851639)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-07-02
GLUCOMETER M BLOOD GULCOSE METER (K855202)Miles Laboratories, Inc.1986-07-02
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD (K862276)Intermedics, Inc.1986-07-02
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED (K860999)Ciba Corning Diagnostics Corp.1986-07-02
V-TREND EIA TSH (K861918)V-Tech, Inc.1986-07-02
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (K860924)Monoclonal Antibodies, Inc.1986-07-02
DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS (K860867)Medical Components, Inc.1986-07-02
PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP (K860634)Panasonic Co. Div. Matsu Elec. Corp. America1986-07-01
FTI 100 MEDICAL THERMAL IMAGER (K862416)Parexel Intl. Corp.1986-07-01
FUJITSU MALLEABLE - TIP BRAIN SPATULA (K862331)Downs Surgical , Ltd.1986-07-01
CHLORIDE PROCEDURE (K861674)Data Medical Associates, Inc.1986-07-01
HCG IRMA, CAT. NO. CR-1501 (K862007)Pacific Biotech, Inc.1986-07-01
BLOOD UREA NITROGEN (BUN) PROCEDURE (K861666)Data Medical Associates, Inc.1986-07-01
INORGANIC PHOSPHORUS PROCEDURE (K861661)Data Medical Associates, Inc.1986-07-01
ERIE-NEB (K861865)Erie Medical1986-07-01
CHOLESTEROL CALIBRATORS (K861314)Sigma Diagnostics, Inc.1986-07-01
ELEFIX ELECTRODE CREAM (K860210)Nihon Kohden America, Inc.1986-07-01
AMYLASE PROCEDURE (K861664)Data Medical Associates, Inc.1986-07-01
ROTAVIRUS LATEX AGGLUTINATION ASSAY (K861172)Bartels Immunodiagnostic Supplies, Inc.1986-07-01
BICARBONATE PROCEDURE (K861673)Data Medical Associates, Inc.1986-07-01
BYRON SUCTION TIPS (K861878)Byron Medical1986-07-01
S&W TYPE 888 ELECTRODE (K861158)National Medical Technology1986-07-01
NON-ADHERING DRESSING WITH POVIDONE-IODINE (K861384)Johnson & Johnson Professionals, Inc.1986-07-01
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II (K862186)Bio-Rad1986-07-01
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 (K861696)Boehringer Mannheim Corp.1986-07-01
CAVAFIX, CENTRAL VENOUS CATHETER KIT (K861479)Burron Medical Products, Inc.1986-07-01
UNISKAN II (K861897)Flow Laboratories, Inc.1986-07-01
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (K862256)Sterling Diagnostics, Inc.1986-07-01
TRIGLYCERIDE (TRINDER) PROCEDURE (K861670)Data Medical Associates, Inc.1986-07-01
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (K862415)Parexel Intl. Corp.1986-07-01
CEPHALOSTAT (K860835)Dallas Dental Co.1986-07-01
CREATININE PROCEDURE (K861655)Data Medical Associates, Inc.1986-07-01
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS (K862299)Amresco, Inc.1986-07-01
MODIFIED MODELS 8320/8322/8329/8316/8317/8318 (K861719)Medtronic Vascular1986-07-01
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM (K862375)Grandcor Medical Systems1986-07-01
UREA NITROGEN (GLDH) REAGENT SET (UV) (K862210)Sterling Diagnostics, Inc.1986-07-01
SOMAS LIQUID URINE CONTROL (K862179)Somas Medical Industries, Inc.1986-07-01
INTELLIJECT INFUSION PUMP (K861207)Intelligent Medicine, Inc.1986-06-30
META - HEALTH MODEL MTG III (K861771)Meta Health, Inc.1986-06-30
ARTIS ULTRASOUND IMAGING SYSTEM (K853565)Philips Medical Systems (Cleveland), Inc.1986-06-30
CARDIOSCAN DOPPLER OPTION (K860579)Interspec, Inc.1986-06-30
STORZ COMPUSCAN 68K (K861335)Storz Instrument Co.1986-06-30
RAPID BACTERIURIA SCREEN (RBS) (K862195)New Horizons Diagnostics Co.1986-06-30
ENZYMUN TEST TBG (K862109)Boehringer Mannheim Corp.1986-06-30
HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER (K862020)Intertech/Ohio1986-06-30
INTELLIJECT MEDICATION SYRINGE (K861208)Intelligent Medicine, Inc.1986-06-30
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) (K862216)Labsystems, Inc.1986-06-30
EMIT QUINIDINE ASSAY (K862214)Syva Co.1986-06-27
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) (K861387)Eastman Kodak Company1986-06-27
LYOFOAM WOUND DRESSINGS (K860085)Acme United Corp.1986-06-27
SUCROSEP HUMAN PROLACTIN (HPR) IRMA (K861271)Boots-Celltech Diagnostics, Inc.1986-06-27
TOTAL BILIRUBIN TEST KIT (K861998)Ciba Corning Diagnostics Corp.1986-06-27
TB SERIES BIPOLAR PACING LEADS (K861403)Oscor Medical Corp.1986-06-27
TSH IRMA KIT (K862249)Pacific Biotech, Inc.1986-06-27
TWIN TRIGLYCERIDES GPO/CHOLESTEROL (K861793)Boehringer Mannheim Corp.1986-06-27
POLYPECTOMY SNARE (K862060)Endovations1986-06-27
DERMISTRIP (K861972)Kells Medical, Inc.1986-06-27
MEDISYSTEMS PHERESIS NEEDLE (K862002)Medisystems Corp.1986-06-27
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT (K862218)Diagnostic Products Corp.1986-06-27
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM (K861580)Cetus Corp.1986-06-27
TWIN BUN/GLUCOSE (K861775)Boehringer Mannheim Corp.1986-06-27
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE (K861361)Serono Diagnostics, Inc.1986-06-27
OSTEONICS ELBOW PROSTHESIS (K861680)Osteonics Corp.1986-06-27
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