Atlas FDA

1986

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

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RecordFirmDate
MODEL 320 TWO CHANNEL AUDIOMETER (K863984)Virtual Corp.1986-11-18
MICROSCREEN I HEARING TESTER (K863979)Microscreen1986-11-18
FORTEC MI-100, BLOOD PRESSURE METER (K862200)Fortec Electronic Corp./Nam Tai1986-11-18
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32) (K860801)Cadwell Laboratories, Inc.1986-11-18
PROPHY CARE SOLUTION (K864215)Imd, Inc.1986-11-18
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (K864307)Smith & Nephew, Inc.1986-11-18
SARNS SAFETY LOOP (K863593)3M Health Care, Sarns1986-11-18
DREAM DAM (K864096)Dental Dam, Inc.1986-11-18
STOCKERT-SHILEY CAPS HLM INTERFACE (K863541)Shiley, Inc.1986-11-18
BI-TEMP TEMPERATURE MONITOR (K863987)Respiratory Support Products, Inc.1986-11-18
LEUKOPLAST(R) POROUS AND SPORT TAPE (K864160)Beiersdorf, Inc.1986-11-17
LASER SURGICAL ROD (K862815)Lifestream Int'L, Inc.1986-11-17
BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM) (K862714)Electro-Diagnostic Instruments1986-11-17
DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER (K861023)Diagnostic Electronics Corp.1986-11-17
NORELCO ELECTRONIC DIGITAL BP METER HC3030 (K854279)Philips Park1986-11-17
GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN (K864193)Gaw, Inc.1986-11-17
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES (K862720)Sonicaid, Inc.1986-11-17
LUXTEC LOUPES FOR SURGICAL VISION (K864386)Luxtec Corp.1986-11-17
MBK SURGEONS'(STERILE & NON-STERILE) SURG GLOVES (K864165)Mbk Medical Gloves Co., Ltd.1986-11-17
UNITED WOUND COVERING, PACKAGE OF 5 (K863389)United Medical1986-11-17
SURGICAL SKIN MARKER (K864371)Myocure, Inc.1986-11-17
NORELCO DIGITAL BLOOD PRESSURE METER HC3001 (K855048)Philips Park1986-11-17
TENSOTAPE SURGICAL ADHESIVE TAPE (K863865)Smith & Nephew, Inc.1986-11-14
CHESEBROUGH POND'S HYDROCOLLOID DRESSING (K862803)Chesebrough-Pond'S U.S.A. Co.1986-11-14
C' AIRECUSH SEAT CUSHION (K864109)Medical Industries America, Inc.1986-11-14
VOCAID, ELECTRONIC VOCAL AID (K864204)Texas Instruments, Inc.1986-11-14
MODEL Q55XT POWERED TREADMILL (K864013)Quinton, Inc.1986-11-14
PUSH CUSH (K864108)Medical Industries America, Inc.1986-11-14
FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 (K862448)Life Design Systems, Inc.1986-11-14
FAULKNER FORCEPS (K864071)Staar Surgical Co.1986-11-13
KEYNOTE (K863995)Sensory Aids Corp.1986-11-13
ORION 3001, LASER PHOTOCOAGULATOR (K864063)G. Rodenstock Instrumente GmbH1986-11-13
LIFE-PORT IMPLANTABLE VASCULAR ACCESS (K853827)Strato Medical Corp.1986-11-13
MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID (K864031)Int'L Hearing Aids, Inc.1986-11-13
INTESTOPLANT (K862412)Burron Medical Products, Inc.1986-11-13
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 (K863719)Technicon Instruments Corp.1986-11-13
MECHANICAL OXYGEN REGULATOR (K864127)Travomed, Inc.1986-11-13
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (K863756)Nova-Ventrx1986-11-13
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (K863874)Electro-Nucleonics Laboratories, Inc.1986-11-13
TERUMO SENSIBEAD(TM) EIA HLH KIT (K863929)Terumo Medical Corp.1986-11-13
THROMBOPLASTIN.R (K864274)American Dade1986-11-13
MODEL T-1 OXYGEN ANALYZER (K863158)Chrysalis Systems, Inc.1986-11-13
UBI MAGIWEL(TM) FSH QUANTITATIVE (K864080)United Biotech, Inc.1986-11-13
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (K864037)Kera Corp.1986-11-13
MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID (K864028)Int'L Hearing Aids, Inc.1986-11-13
IMMUNO-CEPT D (BETA-MONOCLONAL) (K863741)Immunostics Co., Inc.1986-11-13
A-GENT(TM) LIQUID GLUCOSE TRINDER (K863948)Abbott Laboratories1986-11-13
AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID (K864029)Int'L Hearing Aids, Inc.1986-11-13
GLUCOSE OXIDASE (K863926)Tech-Co, Inc.1986-11-13
SERUM VANCOMYCIN TOXICOLOGY CONTROL (K862419)Utak Laboratories, Inc.1986-11-13
RAPID ACID FAST STAIN (K864033)Sigma Diagnostics, Inc.1986-11-13
VISION (TM) CALCIUM (K863670)Abbott Laboratories1986-11-13
Q101 DIAGNOSTIC SPIROMETER (K863300)Quinton, Inc.1986-11-13
THROMBOPLASTIN.C (K864273)American Dade1986-11-13
SKIN PURE (K862799)Nihon Kohden America, Inc.1986-11-13
OPTI-BRUSH (K864157)Willmar Contact Lens Clinic1986-11-13
HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) (K864186)Hill-Rom, Inc.1986-11-13
HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS (K864172)Hill-Rom, Inc.1986-11-13
CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY (K863363)Cytotech, Inc.1986-11-13
MACULOSCOPE(TM) (K863956)Doran Instruments, Inc.1986-11-13
THROMBOPLASTIN.FS (K864272)American Dade1986-11-13
BENZODIAZEPINES TOXICOLOGY CONTROL (K862418)Utak Laboratories, Inc.1986-11-13
PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID (K864069)Austin Biological Laboratories1986-11-13
MODEL 35-B ALL LEVEL COT (K864269)Ferno-Washington, Inc.1986-11-13
RECOVER (K863401)Scientific Pharmaceuticals, Inc.1986-11-13
MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID (K864030)Int'L Hearing Aids, Inc.1986-11-13
ERYTHOCYTE CREATINE (K852767)Panmed, Inc.1986-11-13
ABBOTT B2-MICROGLOBULIN RIA (K864130)Abbott Laboratories1986-11-12
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER (K862198)Perry Baromedical Services1986-11-12
PC-DISPLAY (K862309)Hi-Tech Medical Systems, Inc.1986-11-12
BIOSOICS SPHINCTER TRAINING SYSTEM (K862683)Biosonics, Inc.1986-11-12
K-STIK DEFIBRILLATION PADS (K863899)Katecho, Inc.1986-11-12
PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH (K862098)Hall/Mccollum Laboratories, Inc.1986-11-12
PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (K863625)Windsor Laboratories, Inc.1986-11-10
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307 (K863096)Siemens Medical Solutions USA, Inc.1986-11-10
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX (K862613)Gen-Probe, Inc.1986-11-10
TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER (K864161)Toob-Cheq, Inc.1986-11-10
CHARTER LABORATORIES INC. LENS LUBRICANT (K863974)Paco Pharmaceutical Services, Inc.1986-11-10
ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (K860467)Medcraft Corp.1986-11-10
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX (K862614)Gen-Probe, Inc.1986-11-10
BOVIE ULTRASONIC SURGICAL SYSTEM (K855138)Clinical Technology Corp.1986-11-10
OPTEC 1000 DMV (K863509)Stereo Optical Co., Inc.1986-11-10
CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON (K852547)Cortronic Corp.1986-11-10
HIGH VELOCITY CW DOPPLER SYSTEM (K862841)Biosound, Inc.1986-11-10
C-IOO MOBILE CINE CT UNIT (K864046)Imatron, Inc.1986-11-10
EXETER OPERATING LOUPE (K863983)Exeter Instruments, Inc.1986-11-10
3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305 (K863043)Siemens Medical Solutions USA, Inc.1986-11-10
3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306 (K863041)Siemens Medical Solutions USA, Inc.1986-11-10
PORTABLE OXYGEN GENERATOR (K864045)Mountain Medical Equipment, Inc.1986-11-07
BIOCHEM CO/OX 1000 (K863186)Biochem International, Inc.1986-11-07
CUSTOM IN-THE-EAR (K863975)Gn Danavox, Inc.1986-11-07
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY (K863782)Aalba Dent, Inc.1986-11-07
VENT-PLANT DENTAL IMPLANT, OSSEOLOCK AND ROBUTMENT (K863755)Vent-Plant Corporation, Inc.1986-11-07
GAMBRO FLUID CONTROL MONITOR FCM 10-1 (K864094)Gambro, Inc.1986-11-07
EYE PAD, COTTON, GAUZE COVERED (K864023)Fraass Survival Systems, Inc.1986-11-07
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM (K864087)Medical Associated Services, Inc.1986-11-07
COLBY LEVEL ALARM (K863955)Respiratory Care, Inc.1986-11-07
ECG MODULE (K862553)Elscint, Inc.1986-11-07
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (K862919)Transpirator Technologics, Inc.1986-11-07
ADEC 1005-C CHAIR (K864072)Cherne Industries, Inc.1986-11-07
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Track 1986 automatically

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