Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VEOLAR VENTILATOR (K881482)Hamilton Medical, Inc.1988-06-16
PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM (K881514)Hall Laboratories, Inc.1988-06-16
UROLOGICAL CATHETER (K881646)Coeur Laboratories, Inc.1988-06-16
SELF-RETAINING SOFT TISSUE RETRACTOR (K882075)Karlin Technology, Inc.1988-06-16
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C (K881269)Omron Electronics, Inc.1988-06-16
HUMID-VENT 2 S FLEX (K881656)Gibeck Respiration1988-06-16
WITT BIOMEDICAL VX-80 (K880258)Witt Biomedical Corporation1988-06-16
SPARE MS 700 TENS ELECTRODE (K881871)Lectec Corp.1988-06-16
VITEK YEAST BIOCHEMICAL CARD (K881925)Vitek Systems, Inc.1988-06-16
RESUSCITATION BAG CONTROLLER (RBC) (K882278)Physician Engineered Products, Inc.1988-06-16
MX1002 CABLE-CAL TM (K880696)Medex, Inc.1988-06-15
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM (K880353)Ciba Corning Diagnostics Corp.1988-06-15
BIOLOGICAL OHM METER, BES 200Z (K880926)Bioelectrical Sciences, Inc.1988-06-15
EMBOLECTOMY CATHETER(MODIFIED) (K881455)Cathlab Corp.1988-06-15
LIGHT, SURGICAL ACCESSORIES (K882132)Charles Polo & Co., Inc.1988-06-15
MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT (K881671)Manan Medical Devices1988-06-15
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C (K881602)Omron Tateisi Electronics Co.1988-06-15
TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 (K882128)Tecnol New Jersey Wound Care, Inc.1988-06-15
BICARBONATE (CO2) REAGENT-2 VIAL (K881938)Trace Scientific , Ltd.1988-06-15
MURSE RETRACTOR (K882112)Euro-American Marketing Group, Inc.1988-06-15
ADD-A-SHIELD (K882026)Bfd, Inc.1988-06-15
COVERALL SHIELD (K882028)Bfd, Inc.1988-06-15
SOFT TISSUE BIOPSY DEVICE (K882013)Ocean Medical Products, Ltd.1988-06-15
SURGICAL INSTRUMENTS (K881937)Far East Intl. Trading Corp.1988-06-15
ZINC FORMALIN CONCENTRATE (K882268)Anatech, Ltd.1988-06-15
EASY WASHER II MICROPLATE WASHER (K881797)Slt Labinstruments, Inc.1988-06-15
JEDMED MICRO CCD CAMERA SYSTEM (K882166)Jedmed Instrument Co.1988-06-15
OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403C (K881601)Omron Tateisi Electronics Co.1988-06-15
MONITRON SYSTEM (K874148)American Health Products, Inc.1988-06-15
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (K881449)Baxter Healthcare Corp1988-06-15
COMBO-SHIELD (K882027)Bfd, Inc.1988-06-15
SURGICAL BLADE (K881638)Far East Intl. Trading Corp.1988-06-15
MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B (K881898)Atlantic Antibodies1988-06-14
MUCUS TRAP OR SUCTION TRAP (K881149)Ferguson Medical1988-06-14
HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC (K875110)Incstar Corp.1988-06-14
ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (K881220)Laboratoire Ccd C/O Washington Regulatory Services1988-06-14
OMNI-VENT, SERIES D/MRI (K881420)Stein-Gates Medical Equipment, Inc.1988-06-14
AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904 (K881129)Boehringer Laboratories1988-06-14
SANAPLAST (K881397)Nebo Industries1988-06-14
CERVICATH (K881414)Epcom Medical Systems, Inc.1988-06-14
LIGHT BOND (K880793)Reliance Orthodontic Products, Inc.1988-06-13
CMI VACUUM DELIVERY SYSTEM #003C AND #004C (K881306)Challenge Mfg., Inc.1988-06-13
MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER (K882063)Zest Anchors, Inc.1988-06-13
MAXIMUM CURE SEALANT (K880791)Reliance Orthodontic Products, Inc.1988-06-13
BIONIC-TOOTH-PLANT MODEL A-1 (K873437)Larry R. Ashkinazy, D.D.S.1988-06-13
DENTORIDGE(TM) HYDROXYYLAPATITE (K882098)Norian Corp.1988-06-13
CONDOM (PROPHYLACTIC) (K880463)Health Technologies Intl.1988-06-13
ENDOSSEOUS DENTAL IMPLANT (K881924)Bone Anchorage Systems, Inc.1988-06-13
CLEARFIL PHOTO CORE (K882006)Kuraray Co.1988-06-13
JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS (K882126)J.F. Jelenko & Co., Inc.1988-06-13
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) (K881967)Challenge Mfg., Inc.1988-06-13
VENOVALVE(TM) (K881234)Abbott Laboratories1988-06-13
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH (K881215)Baxter Healthcare Corp1988-06-13
MODEL 800 O.B. DATA ARCHIVAL SYSTEM (K880419)Ge Medical Systems Information Technologies1988-06-10
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER (K881760)American Electromedics Corp.1988-06-10
SIMPLEX UNIVERSAL HEATED TUBING SLEEVE (K881451)Simplex Medical Corp.1988-06-10
T.E.N.S. ELECTRODE NON-STERILE (K881444)Tens Accessories, Inc.1988-06-10
COBAS EIA(TM) PHOTOMETER (K881877)Roche Diagnostic Systems, Inc.1988-06-10
CRANK FRAME RETRACTOR (K882071)Karlin Technology, Inc.1988-06-10
AMBULATORY BLOOD PRESSURE MONITOR (K873764)Pulsetrend, Inc.1988-06-10
MAMEX DC MAG MG12 (K881506)Orion Corp.1988-06-10
MODEL 9216 RESPIRATION/HEART RATE MONITOR (K881266)Aequitron Medical, Inc.1988-06-10
HDL CHOLESTEROL KIT (K881244)Trace Scientific , Ltd.1988-06-10
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM (K880839)Phoenix Imaging1988-06-10
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL (K880289)Datascope Corp.1988-06-10
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG. (K881122)Medical Associated Services, Inc.1988-06-10
FLOSS CARD (K882164)Arthur Blank & Co., Inc.1988-06-10
OXY-CATH (K881428)Pulmonary Medical Devices, Inc.1988-06-10
ACE SCREW REMOVAL TREPHINE (K882008)Buckman Co., Inc.1988-06-10
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY (K881855)Syva Co.1988-06-10
PHARMACIA IGE RIACT (K881892)Pharmacia, Inc.1988-06-10
IMMUNOGLOBULIN A TEST SYSTEM (K881827)The Binding Site, Ltd.1988-06-10
JETPOLISHER(TM) (K875340)Young Dental Manufacturing Co. 1, LLC1988-06-10
MAMEX DC MG11 (K881505)Orion Corp.1988-06-10
VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT (K880041)D-R Medical Systems, Inc.1988-06-10
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (K864159)Chem-Elec, Inc.1988-06-10
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (K881773)Casco Standards1988-06-10
HUMID-VENT 2 S (K881644)Gibeck Respiration1988-06-10
IQ HDL CHOLESTEROL (K881891)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-10
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) (K880576)Reagents Applications, Inc.1988-06-10
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK (K881330)Cobe Laboratories, Inc.1988-06-10
S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM (K882190)Harbor Medical Devices, Inc.1988-06-09
SHILEY FEMORAL CANNULAE INTRODUCER KIT (K881073)Shiley, Inc.1988-06-09
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT (K880040)D-R Medical Systems, Inc.1988-06-09
RIGHT ATRIAL CATHETER INSERTION TRAY (K881352)Quinton, Inc.1988-06-09
DISPOSABLE CATHETER PRESSURE TRANSDUCER (K874165)Deseret Medical, Inc.1988-06-09
LIFESTAT 1600 PRINTER (K881346)Physio-Control Corp.1988-06-09
DURACLEAN DAILY CLEANER (K881987)Allergan Optical1988-06-09
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670)Molecular Biosystems, Inc.1988-06-08
NOVA LITE(TM) AUTOANTIBODY CONTROLS (K881340)Inova Diagnostics, Inc.1988-06-08
EXTENDED MULTIPURPOSE TRANSDUCER RANGE (K880580)Pie Medical USA BV1988-06-08
RID PLATE READER (K881174)The Binding Site, Ltd.1988-06-08
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM (K881774)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-08
TEMPA-DOT CLINICAL THERMOMETER SHEATH (K881286)Pymah Corp.1988-06-08
IMPRES-MB (K881801)Intl. Immunoassay Laboratories, Inc.1988-06-08
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT (K881355)Amersham Corp.1988-06-08
DRY COMFORT DISPOSABLE UNDERPAD (K881969)Health Tec, Inc.1988-06-07
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER (K881099)Phonic Ear, Inc.1988-06-07
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY (K881617)Granbio, Inc.1988-06-07
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN (K881798)Technicon Instruments Corp.1988-06-07
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Every clearance here is in the API, with alerts when new ones post.