FDA 510(k) clearances — page 1365

176,637 clearances on record, most recent first.

Clearances — page 1365

136,401–136,500 of 176,637

K880480 — DUNFORD SURGEON'S STERILE GLOVESPhillippine Radiant C/O U.S. Polymer Industries·Product code KGO·1988-06-17
K880503 — MDL-1 LASERTRIPTERCandela Laser Corp.·Product code FFK·1988-06-17
K880504 — MCT MEDICAL BROWNE UROSCAN URODYNAMICMct Medical, Inc.·Product code EXY·1988-06-17
K881252 — PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGEDeknatel, Inc.·Product code GCX·1988-06-17
K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDEPfizer, Inc.·Product code LXI·1988-06-17
K882062 — MODEL BIOSTARTargus Concepts·Product code HCC·1988-06-17
K882069 — SPINAL DISTRACTORS, SPANNERSKarlin Technology, Inc.·Product code LXH·1988-06-17
K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTESKarlin Technology, Inc.·Product code JXH·1988-06-17
K882077 — MICRODISCECTOMY CURRETTESKarlin Technology, Inc.·Product code LXH·1988-06-17
K882169 — SURGICAL DUCT CLAMP (VINE)Henley Intl.·Product code GDJ·1988-06-17
K882170 — RX ASPENJeneric/Pentron, Inc.·Product code EJH·1988-06-17
K882203 — NEOTECH UNIVERSAL ADAPTERNeotech Products, Inc.·Product code BZA·1988-06-17
K882297 — 1/2 CM REAR TIP EXTENDER (RTE)American Medical Systems, Inc.·Product code FHN·1988-06-17
K874366 — ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201Cordis Leads, Inc.·Product code DTB·1988-06-16
K880258 — WITT BIOMEDICAL VX-80Witt Biomedical Corporation·Product code DXG·1988-06-16
K880454 — AT EASE STRESS PADHospital Specialty Co.·Product code EYQ·1988-06-16
K880694 — B. CAT CONFIRMScott Laboratories, Inc.·Product code JTO·1988-06-16
K881269 — OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701COmron Electronics, Inc.·Product code DXN·1988-06-16
K881293 — SHERIDAN ELECTROSURGERY PROTECTION FILTERSheridan Catheter Corp.·Product code BZT·1988-06-16
K881321 — BLOOD/SOLUTION SET W/PRESSURE PUMPBaxter Healthcare Corp·Product code FPA·1988-06-16
K881472 — SL02 OXYGEN ANALYZERSalter Labs·Product code CCL·1988-06-16
K881473 — SL01 OXYGEN ANALYZERSalter Labs·Product code CCL·1988-06-16
K881482 — VEOLAR VENTILATORHamilton Medical, Inc.·Product code CBK·1988-06-16
K881514 — PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEMHall Laboratories, Inc.·Product code BSK·1988-06-16
K881646 — UROLOGICAL CATHETERCoeur Laboratories, Inc.·Product code KOD·1988-06-16
K881656 — HUMID-VENT 2 S FLEXGibeck Respiration·Product code BYD·1988-06-16
K881856 — BIOTROL CREATININE H.P. REAGENTBiotrol, USA, Inc.·Product code CGX·1988-06-16
K881871 — SPARE MS 700 TENS ELECTRODELectec Corp.·Product code GXY·1988-06-16
K881872 — TENS ELECTRODE MODEL 238PLectec Corp.·Product code GXY·1988-06-16
K881925 — VITEK YEAST BIOCHEMICAL CARDVitek Systems, Inc.·Product code JXB·1988-06-16
K882074 — SUCTION RETRACTORSKarlin Technology, Inc.·Product code GAD·1988-06-16
K882075 — SELF-RETAINING SOFT TISSUE RETRACTORKarlin Technology, Inc.·Product code GAD·1988-06-16
K882078 — SPINAL SURGERY FRAMEKarlin Technology, Inc.·Product code FWZ·1988-06-16
K882278 — RESUSCITATION BAG CONTROLLER (RBC)Physician Engineered Products, Inc.·Product code BTM·1988-06-16
K882320 — KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8Eastman Kodak Company·Product code IXW·1988-06-16
K882335 — DISPOSABLE SYRINGEBaxter Healthcare Corp·Product code FMF·1988-06-16
K882357 — MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LYStat Path·Product code KEW·1988-06-16
K874148 — MONITRON SYSTEMAmerican Health Products, Inc.·Product code DRT·1988-06-15
K880353 — CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEMCiba Corning Diagnostics Corp.·Product code GKR·1988-06-15
K880696 — MX1002 CABLE-CAL TMMedex, Inc.·Product code DXG·1988-06-15
K880926 — BIOLOGICAL OHM METER, BES 200ZBioelectrical Sciences, Inc.·Product code DSB·1988-06-15
K881449 — EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116Baxter Healthcare Corp·Product code LXN·1988-06-15
K881455 — EMBOLECTOMY CATHETER(MODIFIED)Cathlab Corp.·Product code DXE·1988-06-15
K881601 — OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM403COmron Tateisi Electronics Co.·Product code DXN·1988-06-15
K881602 — OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703COmron Tateisi Electronics Co.·Product code DXN·1988-06-15
K881638 — SURGICAL BLADEFar East Intl. Trading Corp.·Product code GES·1988-06-15
K881671 — MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KITManan Medical Devices·Product code FMI·1988-06-15
K881797 — EASY WASHER II MICROPLATE WASHERSlt Labinstruments, Inc.·Product code JJQ·1988-06-15
K881937 — SURGICAL INSTRUMENTSFar East Intl. Trading Corp.·Product code HRQ·1988-06-15
K881938 — BICARBONATE (CO2) REAGENT-2 VIALTrace Scientific , Ltd.·Product code KHS·1988-06-15
K882013 — SOFT TISSUE BIOPSY DEVICEOcean Medical Products, Ltd.·Product code DWO·1988-06-15
K882026 — ADD-A-SHIELDBfd, Inc.·Product code FXX·1988-06-15
K882027 — COMBO-SHIELDBfd, Inc.·Product code FXX·1988-06-15
K882028 — COVERALL SHIELDBfd, Inc.·Product code FXX·1988-06-15
K882112 — MURSE RETRACTOREuro-American Marketing Group, Inc.·Product code GAD·1988-06-15
K882128 — TECNOL TIGER PAWS PRODUCT NUMBER 47705-010Tecnol New Jersey Wound Care, Inc.·Product code FXP·1988-06-15
K882132 — LIGHT, SURGICAL ACCESSORIESCharles Polo & Co., Inc.·Product code FTA·1988-06-15
K882166 — JEDMED MICRO CCD CAMERA SYSTEMJedmed Instrument Co.·Product code FWD·1988-06-15
K882268 — ZINC FORMALIN CONCENTRATEAnatech, Ltd.·Product code IGG·1988-06-15
K875110 — HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISCIncstar Corp.·Product code DHB·1988-06-14
K881129 — AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904Boehringer Laboratories·Product code CAC·1988-06-14
K881149 — MUCUS TRAP OR SUCTION TRAPFerguson Medical·Product code KDQ·1988-06-14
K881220 — ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLERLaboratoire Ccd C/O Washington Regulatory Services·Product code HFE·1988-06-14
K881397 — SANAPLASTNebo Industries·Product code KGX·1988-06-14
K881414 — CERVICATHEpcom Medical Systems, Inc.·Product code HDR·1988-06-14
K881420 — OMNI-VENT, SERIES D/MRIStein-Gates Medical Equipment, Inc.·Product code CBK·1988-06-14
K881898 — MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN BAtlantic Antibodies·Product code MSJ·1988-06-14
K873437 — BIONIC-TOOTH-PLANT MODEL A-1Larry R. Ashkinazy, D.D.S.·Product code DZE·1988-06-13
K880463 — CONDOM (PROPHYLACTIC)Health Technologies Intl.·Product code HIS·1988-06-13
K880791 — MAXIMUM CURE SEALANTReliance Orthodontic Products, Inc.·Product code DYH·1988-06-13
K880793 — LIGHT BONDReliance Orthodontic Products, Inc.·Product code DYH·1988-06-13
K881215 — CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATHBaxter Healthcare Corp·Product code FOZ·1988-06-13
K881234 — VENOVALVE(TM)Abbott Laboratories·Product code FPA·1988-06-13
K881306 — CMI VACUUM DELIVERY SYSTEM #003C AND #004CChallenge Mfg., Inc.·Product code HDB·1988-06-13
K881924 — ENDOSSEOUS DENTAL IMPLANTBone Anchorage Systems, Inc.·Product code DZE·1988-06-13
K881967 — CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)Challenge Mfg., Inc.·Product code HDB·1988-06-13
K882006 — CLEARFIL PHOTO COREKuraray Co.·Product code EBF·1988-06-13
K882063 — MAGNE-DENT MAGNET/ZEST RETROFIT KEEPERZest Anchors, Inc.·Product code EGG·1988-06-13
K882098 — DENTORIDGE(TM) HYDROXYYLAPATITENorian Corp.·Product code LYC·1988-06-13
K882126 — JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYSJ.F. Jelenko & Co., Inc.·Product code EJT·1988-06-13
K864159 — SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODChem-Elec, Inc.·Product code CHH·1988-06-10
K873764 — AMBULATORY BLOOD PRESSURE MONITORPulsetrend, Inc.·Product code DXN·1988-06-10
K875340 — JETPOLISHER(TM)Young Dental Manufacturing Co. 1, LLC·Product code KOJ·1988-06-10
K880041 — VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFTD-R Medical Systems, Inc.·Product code DSY·1988-06-10
K880289 — DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALLDatascope Corp.·Product code DSP·1988-06-10
K880419 — MODEL 800 O.B. DATA ARCHIVAL SYSTEMGe Medical Systems Information Technologies·Product code HGM·1988-06-10
K880576 — RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)Reagents Applications, Inc.·Product code CJY·1988-06-10
K880839 — AI 5200 DIAGNOSTIC ULTRASOUND SYSTEMPhoenix Imaging·Product code IYO·1988-06-10
K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.Medical Associated Services, Inc.·Product code BTY·1988-06-10
K881244 — HDL CHOLESTEROL KITTrace Scientific , Ltd.·Product code LBR·1988-06-10
K881266 — MODEL 9216 RESPIRATION/HEART RATE MONITORAequitron Medical, Inc.·Product code BZQ·1988-06-10
K881330 — COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACKCobe Laboratories, Inc.·Product code DWF·1988-06-10
K881428 — OXY-CATHPulmonary Medical Devices, Inc.·Product code BSY·1988-06-10
K881444 — T.E.N.S. ELECTRODE NON-STERILETens Accessories, Inc.·Product code GXY·1988-06-10
K881451 — SIMPLEX UNIVERSAL HEATED TUBING SLEEVESimplex Medical Corp.·Product code BZE·1988-06-10
K881505 — MAMEX DC MG11Orion Corp.·Product code IZH·1988-06-10
K881506 — MAMEX DC MAG MG12Orion Corp.·Product code IZH·1988-06-10
K881644 — HUMID-VENT 2 SGibeck Respiration·Product code BYD·1988-06-10
K881760 — AE1162 CLINICAL/DIAGNOSTIC AUDIOMETERAmerican Electromedics Corp.·Product code EWO·1988-06-10
K881773 — DOCUMENT(TM) DIRECT ISE LINEARITY TEST SETCasco Standards·Product code JJR·1988-06-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.