FDA 510(k) clearances — page 896

176,637 clearances on record, most recent first.

Clearances — page 896

89,501–89,600 of 176,637

K982577 — NEUFINISH RESURFACING CREAMNeutrogena Corp.·Product code MGQ·1998-10-21
K982592 — DOCKING-EXTENSION WIRESchneider (Europe) GmbH·Product code DQX·1998-10-21
K982642 — ECHO-SCREENFischer-Zoth Audiologic Systems, Inc.·Product code EWO·1998-10-21
K982778 — BIODERM FOAM WOUND DRESSINGBioderm, Inc.·Product code KMF·1998-10-21
K982787 — ASTEION CT SCANNER, TSX-021AToshiba America Medical Systems, In.C·Product code JAK·1998-10-21
K982818 — HOSPAL TIPSTOPGambro Healthcare·Product code KMF·1998-10-21
K982862 — RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULEApplicare Medical Imaging, B.V.·Product code LLZ·1998-10-21
K982873 — ZETA MULTIZONE SCN LOCKING NAILHowmedica Corp.·Product code HSB·1998-10-21
K982896 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9Alexander Mfg. Co.·Product code LDD·1998-10-21
K982903 — SULZER ORTHOPEDICS FLUTED STEMSSulzer Orthopedics, Inc.·Product code JWH·1998-10-21
K982931 — THREADED FIXATION PINSgarlato Laboratories, Inc.·Product code JDW·1998-10-21
K982936 — OSTEONICS EXTENDED FEMORAL BEARING HEADOsteonics Corp.·Product code LWJ·1998-10-21
K982953 — TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESBiomet, Inc.·Product code HSB·1998-10-21
K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTSMicroline Pentax, Inc.·Product code GEI·1998-10-21
K982987 — SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMSynthes Spine·Product code MNI·1998-10-21
K982990 — TSRH SPINAL SYSTEMSofamor Danek USA,Inc.·Product code MNI·1998-10-21
K982991 — ANSPACH ACCESS CRANIAL PERFORATORThe Anspach Effort, Inc.·Product code HBF·1998-10-21
K982998 — GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBEGreiner Meditech, Inc.·Product code JKA·1998-10-21
K983053 — ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)Alden Optical Labs., Inc.·Product code LPL·1998-10-21
K983058 — CERALAS D LASER SYSTEM, MODEL # CERALAS D15Ceram Optec, Inc.·Product code GEX·1998-10-21
K983186 — BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHORLinvatec Corp.·Product code MAI·1998-10-21
K983224 — XPS DRILL SYSTEMXomed, Inc.·Product code ERL·1998-10-21
K983258 — MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEMSpinal Concepts, Inc.·Product code MNI·1998-10-21
K983260 — MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEMSpinal Concepts, Inc.·Product code MNI·1998-10-21
K983316 — ULTRACISION 5MM INSTRUMENTSEthicon Endo-Surgery, Inc.·Product code LFL·1998-10-21
K983416 — ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353Boehringer Mannheim Corp.·Product code JGJ·1998-10-21
K981880 — DX-480, ADD ON DIGITAL IMAGERWuestec Medical, Inc.·Product code KPR·1998-10-20
K982699 — UNIGRAFEUnicare Biomedical·Product code LYC·1998-10-20
K982888 — VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEMBoston Scientific Corp·Product code LJT·1998-10-20
K983037 — ROEKO SEALRoeko Ulm, Roescheisen GmbH & Co.·Product code KIF·1998-10-20
K981958 — LEISEGANG VIDEO COLPOSCOPENetoptix Corp.·Product code HEX·1998-10-19
K982299 — SPYGLASS 5 FR ANGIOGRAPHIC CATHETERDaig Corp.·Product code DQO·1998-10-19
K982545 — BMP CABLE SYSTEMBiomet, Inc.·Product code JDQ·1998-10-19
K982548 — MLT 30 LASERMedical Laser Technologies , Ltd.·Product code GEX·1998-10-19
K982671 — SECURALLOYSpecialites Septodont·Product code EJJ·1998-10-19
K982695 — GC RELINEGC America, Inc.·Product code EBI·1998-10-19
K982913 — ZINFOS ZINC PHOSPHATE CEMENTScientific Pharmaceuticals, Inc.·Product code EMA·1998-10-19
K982966 — DISETRONIC PENDisetronic Medical Systems·Product code FMF·1998-10-19
K983052 — PERITRON PERINEOMETER MODEL 9300V OR 9300ACardio Design Pty. , Ltd.·Product code HIR·1998-10-19
K983381 — VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELSParagon Trade Brands, Inc.·Product code HEB·1998-10-19
K983406 — SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FORBanta Healthcare Group, Ltd.·Product code FLL·1998-10-19
K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEMPrinceton Regulatory Assoc.·Product code LHC·1998-10-16
K974774 — ENVY GUIDING CATHETERCook, Inc.·Product code DQO·1998-10-16
K980078 — PENETREASEP.T. Panca Pusaka Deli·Product code FMF·1998-10-16
K980724 — TINAQUANT B 2-MICROGLOBULIN ASSAYBoehringer Mannheim Corp.·Product code JZG·1998-10-16
K980907 — AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYAxis Biochemicals, Asa·Product code LPS·1998-10-16
K981660 — Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersC.R. Bard, Inc.·Product code DSP·1998-10-16
K982281 — SERAQUEST RUBELLA IGMQuest Intl., Inc.·Product code LFX·1998-10-16
K982497 — ARTHROTEK INTERFERENCE SCREWBiomet, Inc.·Product code HWC·1998-10-16
K982499 — COSMO PLUS WITH NICO, MODEL 8200Novametrix Medical Systems, Inc.·Product code BZC·1998-10-16
K982508 — FLEXIMABoston Scientific Corp·Product code FGE·1998-10-16
K982530 — SULLIVAN MIRAGE FULL FACE MASKResmed, Ltd.·Product code BZD·1998-10-16
K982531 — HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEMHowmedica Corp.·Product code HRS·1998-10-16
K982621 — QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150Phamatech·Product code MVO·1998-10-16
K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEMAccumed Intl., Inc.·Product code JOY·1998-10-16
K982866 — NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521Nichols Institute Diagnostics·Product code JZO·1998-10-16
K982917 — B-SYSTEM SILICONESybron Dental Specialties, Inc.·Product code ELW·1998-10-16
K982999 — GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBEGreiner Meditech, Inc.·Product code JKA·1998-10-16
K983002 — MYSTIQUE ULTRASONIC NEBULIZERAirsep Corp.·Product code CAF·1998-10-16
K983409 — V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1Hdc Corp.·Product code FOZ·1998-10-16
K981360 — VINYL PATIENT EXAMINATION GLOVE, POWDEREDGlormed Intl., Inc.·Product code LYZ·1998-10-15
K981565 — BIOCLEAR CONCENTRATEWaggoner Product Development·Product code EIA·1998-10-15
K981888 — SMOKE-EVACBio-Medical Devices, Inc.·Product code GEI·1998-10-15
K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma Diagnostics, Inc.·Product code GJA·1998-10-15
K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KITMedtronic Vascular·Product code DTD·1998-10-15
K982492 — IMCOR DENTAL IMPLANT SYSTEM ACCESSORIESImcor·Product code DZE·1998-10-15
K982606 — AUROFLUID CPFMetalor Dental USA Corp.·Product code EJT·1998-10-15
K982658 — KSEA ENDOSCOPES FOR DENTAL PROCEDURESKARL STORZ Endoscopy-America, Inc.·Product code EIA·1998-10-15
K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYChiron Diagnostics Corp.·Product code MOI·1998-10-15
K982772 — SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COILGe Medical Systems, Inc.·Product code MOS·1998-10-15
K982785 — FILM DIGITIZER MODEL 2905Array Corp.·Product code LMA·1998-10-15
K982872 — TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)Tg Medical Sdn. Bhd.·Product code LYY·1998-10-15
K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAYShield Diagnostics, Ltd.·Product code MSV·1998-10-15
K983391 — IMMULITE 2000 OM-MA MODEL L2KOP2Diagnostic Products Corp.·Product code LTK·1998-10-15
K973198 — VGF-7 VASCULAR GRAFT FLOWMETERMedicard , Ltd.·Product code DPW·1998-10-14
K974713 — BARD HYDROPHILLIC COATED GUIDE WIREC.R. Bard, Inc.·Product code DQX·1998-10-14
K981119 — CARDIOPAL MODEL NUMBER PM20Medicomp, Inc.·Product code DXH·1998-10-14
K981697 — CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEMCambridge Heart, Inc.·Product code DPS·1998-10-14
K981744 — COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDERW. Keith Thornton, D.D.S.·Product code BZD·1998-10-14
K982470 — ECG ELECTRODES APRONTapuz Medical Technology , Ltd.·Product code DRX·1998-10-14
K982479 — EXCEL AMBULATORY EEGExcel Tech. , Ltd.·Product code GWQ·1998-10-14
K982487 — CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MOCardiopulmonary Technologies, Inc.·Product code BZC·1998-10-14
K982935 — SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATORBeckman Coulter, Inc.·Product code KXT·1998-10-14
K974890 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002Acutek Adhesive Specialties, Inc.·Product code MGP·1998-10-13
K974892 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012Acutek Adhesive Specialties, Inc.·Product code MGP·1998-10-13
K980820 — PHILIPS EASYGUIDEPhilips Medical Systems, Inc.·Product code HAW·1998-10-13
K981634 — BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLSBiocircuits Corp.·Product code LTJ·1998-10-13
K981645 — TITANIUM HEMOSTATIC CLIPVitalitec Int'L., Inc.·Product code FZP·1998-10-13
K981709 — COAGULATION FACTOR V DEFICIENT PLASMADade Behring, Inc.·Product code GJT·1998-10-13
K981841 — BREATHE EASY, MODELS AD AND CDRespiraid , Ltd.·Product code FRF·1998-10-13
K982688 — SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCKSpectrum Designs, Inc.·Product code MIB·1998-10-13
K982871 — DRUG CALIBRATOR IIDade Behring, Inc.·Product code DKB·1998-10-13
K982939 — BTF THIN FILM WOUND DRESSINGBioderm, Inc.·Product code MGP·1998-10-13
K982982 — MINI-FIXATOR FOR COLLES FRACTURESBiomet, Inc.·Product code HRS·1998-10-13
K983056 — INNOVASIVE TIBIAL FASTENERInnovasive Devices, Inc.·Product code MBI·1998-10-13
K983175 — EXTRA-CARE POWDER-FREE EXAMINATION GLOVEUltrawin Sdn Bhd·Product code LYY·1998-10-13
K981323 — COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBENovartis Nutrition Corp.·Product code KNT·1998-10-09
K981591 — VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENTInternational Regulatory Consultants·Product code FAD·1998-10-09
K981597 — RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYRadionics, Inc.·Product code IYE·1998-10-09
K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.·Product code MQS·1998-10-09

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