Atlas FDA

1986

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

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RecordFirmDate
VELCOM-100 (K863210)Waters Instruments, Inc.1986-11-26
RAYLOR(TM) PERIOSTEAL ELEVATORS (K864421)Cedar Surgical, Inc.1986-11-26
VERINOR ALLOY (K864306)Degussa Dental, Inc.1986-11-26
MUSCLE MASTER (BIPOLAR STIMULATOR) (K862685)Modern Systems Technology, Inc.1986-11-25
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM (K863230)Dextra Medical, Inc.1986-11-25
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO (K863476)Scimed Life Systems, Inc.1986-11-25
TRAVELER LT (K862690)Bio-Logic Systems Corp.1986-11-25
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H (K862844)General Electric Co.1986-11-25
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA (K864271)Instrumentation Laboratory CO1986-11-25
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1 (K864506)Spacelabs, Inc.1986-11-25
OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE (K864372)Osteonics Corp.1986-11-25
D100 COMPUTER CARDIAC ANALYSIS SYSTEM (K863231)Dextra Medical, Inc.1986-11-25
DERMATEC ZONE TRANSPARENT DRESSING (K863578)Dermatec, Inc.1986-11-25
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 (K864041)Em Diagnostic Systems, Inc.1986-11-25
LP ARTHROSCOPIC THIGH HOLDING DEVICE (K864513)Twin Falls Orthopedic Associates, P.A.1986-11-25
ESOPHAGEAL RECTAL TEMPERATURE PROBE (K863646)Respiratory Support Products, Inc.1986-11-25
MEDA 2500 T.E.N.S. (K862450)Watlow/Winona, Inc.1986-11-25
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (K864213)Instrumentation Laboratory CO1986-11-25
STERILIZATION WRAPS #620,624,648,640,636,630,612 (K863981)Graham Medical Products1986-11-25
ANAGO ISOLATION MASK (#80-950) (K864116)Anago, Inc.1986-11-25
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY (K864214)Instrumentation Laboratory CO1986-11-25
LUTEINIZING HORMONE (LH-IRMA) RIA KIT (K864144)Immuchem Corp.1986-11-24
UREA NITROGEN(BUN) (K863925)Tech-Co, Inc.1986-11-24
HAYES VAGINAL SHIELD (K862478)Franklin Medical USA, Inc.1986-11-24
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA (K863361)Cooper Lasersonics, Inc.1986-11-24
AMR RESEARCH TONOMETER (K862958)Associated Medical Representatives1986-11-24
ACUSYST-P (CELL CULTURE EQUIPMENT) (K864334)Endotronics, Inc.1986-11-24
RAYLOR(TM) MALLET (K864422)Cedar Surgical, Inc.1986-11-24
MIDDLE EAR VIEWER AND FLUID COLLECTOR (K862903)Steven K. Juhn1986-11-24
GLUCOMETER-E (K863102)J. D. Assoc.1986-11-24
CO-OXIMETER SOLUTIONS (K863825)D.R.G. Scientific Industries1986-11-24
WILLIAMS ORTHOPAEDIC SURGICAL INSTRUMENTS (K864340)Buckman Co., Inc.1986-11-24
CHOLESTEROL (K863927)Tech-Co, Inc.1986-11-24
URIC ACID (K863924)Tech-Co, Inc.1986-11-24
LIQUI-SERA COMBO LIGAND/TDM CONTROLS (K863849)Biodiagnostic Intl1986-11-24
PROGESTERONE SYSTEM BY EIA (K864156)Intl. Bioclinical, Inc.1986-11-24
TRIGLYCERIDES (K863923)Tech-Co, Inc.1986-11-24
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY (K864461)Medsurg Industries, Inc.1986-11-24
FERROFAST (K863109)J. D. Assoc.1986-11-24
PENTRON HIGH STRENGTH PORCELAIN (K864404)Pentron Corp.1986-11-24
IQ UREA NITROGEN (K863901)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-11-24
SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K863915)Shape Products Co.1986-11-24
VISION (TM) GGTP (K864208)Abbott Laboratories1986-11-24
SILIVA EJECTOR/ORAL CAVITY EVACUATOR (K864300)Ardent Intl., Inc.1986-11-24
MULTI-ANALYTE LIN-TROL (K863751)Sigma Diagnostics, Inc.1986-11-24
UREA NITROGEN TEST (K863889)U. S. Diagnostics, Inc.1986-11-24
BILIRUBIN TOTAL (K863056)J. D. Assoc.1986-11-24
CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER (K863583)Laser Media1986-11-24
THERMONUCLEASE AGAR W/TOLUIDINE BLUE (K864205)Remel Co.1986-11-24
BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (K863880)D.R.G. Scientific Industries1986-11-24
DAIG TYPE O4 VS-1 CONNECTOR (K863921)Daig Corp.1986-11-24
URESIL CAROTID SHUNT (K863558)Uresil Corp.1986-11-24
FLEXMEDICS NITINOL ARCH WIRE (K863742)Flexmedics1986-11-24
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 (K864505)Spacelabs, Inc.1986-11-24
RAYLOR(TM) OSTEOTOMES (K864423)Cedar Surgical, Inc.1986-11-24
7.5 MHZ LINEAR SMALL PARTS PROBE (K863338)Siemens Medical Solutions USA, Inc.1986-11-24
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES (K864011)Fraass Survival Systems, Inc.1986-11-22
FISHER PRICE SUNJAMMERS (K864399)Fisher Price1986-11-21
LIFE-WATCH MONITOR LT-8 (K863534)Computerized Medical Systems, Inc.1986-11-21
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE (K863366)Labeltape Meditect, Inc.1986-11-21
CREST CERVICAL TRACTION (K863838)Central Equipment Sales, Inc.1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM (K863859)Hybritech, Inc.1986-11-21
NELLCOR N-200 (PULSE OXIMETER) (K863784)Nellcor, Inc.1986-11-21
LYOFOAM C ODOR-ABSORBING DRESSING (K864084)Acme United Corp.1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN (K863860)Hybritech, Inc.1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA (K863861)Hybritech, Inc.1986-11-21
HALL DUNBAR DRILL GUIDE SYSTEM (K864163)Hall Surgical, Division of Zimmer, Inc.1986-11-20
CANDELA MODEL SPT-1, PULSED DYE LASER (K861179)Candela Corp.1986-11-20
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD (K864287)Intermedics, Inc.1986-11-20
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (K864155)American Edwards Laboratories1986-11-20
630C ELECTROCARDIOGRAPH (K863030)Quinton, Inc.1986-11-20
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD (K864002)Intermedics, Inc.1986-11-20
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE (K860858)Olympus Corp.1986-11-20
EM III DISPOSABLE ELECTRODE (K863845)Electromed Intl., Ltd.1986-11-20
CHIN-FOGARTY INFLATION DEVICE (K863596)American Edwards Laboratories1986-11-20
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM (K863724)Oxford Medilog, Inc.1986-11-20
CLAMPEASE FA (K863427)Freund Medical Products1986-11-20
TERUMO RADIFOCUS GUIDE WIRE (K863138)Terumo Medical Corp.1986-11-20
CASE 12 (K862316)Marquette Electronics, Inc.1986-11-20
SECONDARY SET LOCK (K864338)Travenol Laboratories, S.A.1986-11-19
EFTEKHAR RECHANNELIZATION DRILL GUIDE (K864314)The Anspach Effort, Inc.1986-11-19
AUSTIN MOORE HIP PROSTHESIS (K863896)Kirschner Medical Corp.1986-11-19
SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T (K864195)Respiratory Support Products, Inc.1986-11-19
MALE URINARY STRESS PAD* (K862877)Convatec, A Division of E.R. Squibb & Sons1986-11-19
P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG (K863854)Precision Medical Devices, Inc.1986-11-19
LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS (K864384)Luxtec Corp.1986-11-19
FREE & ACTIVE(TM) ABSORBENT PADS (K862878)Convatec, A Division of E.R. Squibb & Sons1986-11-19
DR.500O OPERATING TABLE (K864295)Koken Mfg Company, Inc.1986-11-19
CATHETER VALVES KV 100 & KV 100EH (K861699)Max Staubli , Ltd.1986-11-19
DR7700 OPERATING TABLE (K864325)Koken Mfg Company, Inc.1986-11-19
MENTOR ALLOPLASTIC SPERMATOCELE (K863565)Mentor Corp.1986-11-19
ZINETICS GASTROMETER (TM) (K862727)Zinetics Medical Technology Corp.1986-11-19
SR-MODEL 230 (MODIFICATION) (K864106)Hirata Sangyo Co. USA, Inc.1986-11-19
LUTEX HEADLIGHT SYSTEMS (K864380)Luxtec Corp.1986-11-19
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM (K862598)Laserscope1986-11-19
DENTAL PROPHY CUPS (VARIOUS TYPES) (K864059)Mission White Dental, Inc.1986-11-19
MODEL (MB-700) BLOOD PRESSURE MONITOR (K863672)Sharp Electronics Corp.1986-11-18
MODIFIED SARNS OXYGENATOR SYSTEM (K863515)3M Health Care, Sarns1986-11-18
MODEL 8 EEG PREAMPLIFIER (K863124)Micro Tronics Corp.1986-11-18
OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE (K863882)Coe Laboratories, Inc.1986-11-18
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Track 1986 automatically

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