FDA 510(k) clearances — page 906

176,637 clearances on record, most recent first.

Clearances — page 906

90,501–90,600 of 176,637

K981469 — CERMAX300 LIGHTSOURCECuda Products Co.·Product code FSS·1998-07-09
K981527 — MENTOR PATHWAY INTRODUCER/DILATORMentor Corp.·Product code QPB·1998-07-09
K981529 — TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWSmith & Nephew, Inc.·Product code JDS·1998-07-09
K981557 — MYCYCLE, HANDMASTER, VICTORYRichvale , Ltd.·Product code IOR·1998-07-09
K981558 — MYCYCLE HANDMASTER, LIGHTRichvale , Ltd.·Product code IOR·1998-07-09
K981571 — MONARCH IOL DELIVERY SYSTEMAlcon Laboratories·Product code KYB·1998-07-09
K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAGETHICON, Inc.·Product code MDM·1998-07-09
K981706 — AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2Abbott Laboratories·Product code JIX·1998-07-09
K981835 — SILIMED MALAR IMPLANTSilimed, LLC·Product code LZK·1998-07-09
K981837 — TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMSMotion Concepts·Product code ITI·1998-07-09
K981850 — SILIMED CHIN IMPLANTSSilimed, LLC·Product code FWP·1998-07-09
K981851 — SILIMED SILICONE CARVING BLOCKSilimed, LLC·Product code MIB·1998-07-09
K981956 — DEGANIA SILICONE IDENTI LOOPSDegania Silicone , Ltd.·Product code DXC·1998-07-09
K982032 — OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSOsteonics Corp.·Product code MEH·1998-07-09
K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.·Product code LJC·1998-07-09
K982224 — VIGIL PROTEIN CONTROLBeckman Coulter, Inc.·Product code JJY·1998-07-09
K974698 — SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.·Product code DSI·1998-07-08
K980501 — SKINTONER SYSTEMFuller Research Corp.·Product code GEX·1998-07-08
K981294 — ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.·Product code FIZ·1998-07-08
K981301 — SPEED-CUT AUTOMATIC BIOPSY SYSTEMGallini U.S., LLC·Product code KNW·1998-07-08
K981483 — EBI DFS JOINT FIXATOR, MODEL 02800Electro-Biology, Inc.·Product code KTT·1998-07-08
K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETERRochester Medical Corp.·Product code EZL·1998-07-08
K981615 — KSEA UROPUMPKARL STORZ Endoscopy-America, Inc.·Product code LJH·1998-07-08
K972255 — PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEMPulse Biomedical, Inc.·Product code LOS·1998-07-07
K972328 — PERCUTANEOUS BREAST BIOPSY (PBB)Urothealth System, Inc.·Product code KNW·1998-07-07
K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETERCypress Medical Products, Ltd.·Product code DXQ·1998-07-07
K974799 — HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATUREInternational Technidyne Corp.·Product code JPA·1998-07-07
K980177 — SUGITRON MODEL: IECEllman Intl., Inc.·Product code GEI·1998-07-07
K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMBaxter Edwards·Product code KRH·1998-07-07
K981321 — BIPOLAR FORCEPS SET (MODULAR)Richard Wolf Medical Instruments Corp.·Product code GEI·1998-07-07
K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTUREGenzyme Surgical Product (Genzyme Biosurgery)·Product code GAR·1998-07-07
K981428 — ANU ICECryoptherapy Pain Relief Products, Inc.·Product code LKX·1998-07-07
K981479 — IL TEST PT-FIBRINOGEN RECOMBINANTInstrumentation Laboratory CO·Product code GJS·1998-07-07
K981488 — GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATIONOak Carolina, Inc.·Product code LYZ·1998-07-07
K981559 — UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAYPharmacia & Upjohn Co.·Product code JZO·1998-07-07
K981592 — ACS:CENTAUR AFPChiron Diagnostics Corp.·Product code LOQ·1998-07-07
K981828 — GALILEO DISPOSABLE HYSTEROSCOPESNetoptix Corp.·Product code HIH·1998-07-07
K981883 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844Boehringer Mannheim Corp.·Product code CIG·1998-07-07
K981930 — UNICAP THYROID PEROXIDASE IGGPharmacia & Upjohn Co.·Product code JZO·1998-07-07
K971252 — SEVRAIN CRANIAL CLAMPIkonos Corp.·Product code GXN·1998-07-06
K974025 — ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.·Product code GFF·1998-07-06
K974715 — ADVANTAGE 3D XRGE Medical Systems·Product code JAK·1998-07-06
K974837 — IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENSIgel Vision Care Pte , Ltd.·Product code LPL·1998-07-06
K980638 — ADI SYPHILIS RPR LIQUID CONTROLSAmpcor Diagnostics, Inc.·Product code GMP·1998-07-06
K980775 — COMPLETE BRAND MULTI-PURPOSE SOLUTIONAllergan, Inc.·Product code LPN·1998-07-06
K980877 — ETEST CEFDINIRAb Biodisk·Product code JWY·1998-07-06
K981262 — CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMValleylab, Inc.·Product code LFL·1998-07-06
K981307 — INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATORInternational Respiratory Systems, Inc.·Product code BTM·1998-07-06
K981308 — INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAGInternational Respiratory Systems, Inc.·Product code BTM·1998-07-06
K981574 — OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTIONAlcon·Product code LPN·1998-07-06
K981773 — DRAGER-VAPOR 19.3Draeger Medical, Inc.·Product code CAD·1998-07-06
K981800 — SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606Equal Diagnostics, Inc.·Product code HIH·1998-07-06
K981882 — CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TESTPrinceton BioMeditech Corp.·Product code MMI·1998-07-06
K982022 — VIGIL HEMOGLOBIN (HBALC) CONTROLSBeckman Coulter, Inc.·Product code JJX·1998-07-06
K973363 — NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633Ml Strategies, Inc.·Product code IWI·1998-07-02
K974868 — SIGMA PLUS MONOPLACE HYPERBARIC CHAMBERPerry Baromedical Corp.·Product code CBF·1998-07-02
K981182 — OSTEOGRAF/N-300Ceramed Dental, LLC·Product code LYC·1998-07-02
K981251 — KYPHON INFLATABLE BONE TAMPKyphon, Inc.·Product code HRX·1998-07-02
K981264 — ARISTON PHCIvoclar USA, Inc.·Product code EBF·1998-07-02
K981335 — ARISTON PHC LINERIvoclar North America, Inc.·Product code EMA·1998-07-02
K981374 — POREX NOSTRIL RETAINERSPorex Surgical, Inc.·Product code LYA·1998-07-02
K981456 — BABY PACIFIER DIGITAL THERMOMETERK-Jump Health Co., Ltd.·Product code FLL·1998-07-02
K982217 — AC/AD LINEARITY VERIFIERSSc Calibrators & Controls, LLC·Product code DIF·1998-07-02
K971975 — CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETERCardima, Inc.·Product code DRF·1998-07-01
K974739 — HAKIM PROGRAMMABLE VALVE SYSTEMJohnson & Johnson Professionals, Inc.·Product code JXG·1998-07-01
K980087 — PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330Pressure Products, Inc.·Product code DXC·1998-07-01
K980913 — CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical , Ltd.·Product code GEI·1998-07-01
K981187 — ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001Arthrex, Inc.·Product code HWC·1998-07-01
K981213 — UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE IRadionics, Inc.·Product code HAW·1998-07-01
K981215 — PSI-TEC LIPOSUCTION ASPIRATORByron Medical·Product code QPB·1998-07-01
K981247 — SILCAST (CODE NAME RD-0118)J.F. Jelenko & Co., Inc.·Product code EJS·1998-07-01
K981486 — STAIR-LIFTGaraventa (Canada) , Ltd.·Product code ING·1998-07-01
K981598 — HERNIA MESH STABILIZERMedivices Co.·Product code GCJ·1998-07-01
K973914 — SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTARSense Technology, Inc.·Product code LXM·1998-06-30
K980362 — MRI COMPATIBLE MONITOR AND ACCESSORIESDatex-Engstrom, Inc.·Product code DPS·1998-06-30
K981121 — AMIGO RTAmigo Mobility Intl., Inc.·Product code INI·1998-06-30
K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESByron Medical·Product code QPB·1998-06-30
K981190 — HIGH IMPEDANCE CARDIAC GATING CABLEGE Medical Systems·Product code LNH·1998-06-30
K981194 — FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTNexa Orthopedics, Inc.·Product code KWH·1998-06-30
K981227 — SYMPHONY 360 REMOTE CONTROL TABLEAcoma Medical Imaging, Inc.·Product code JAA·1998-06-30
K981293 — 7200 ULTRASOUND IMAGING SYSTEMBiosound Esaote, Inc.·Product code IYO·1998-06-30
K981410 — HAMMERSMITH ENDOCAVITARY COILSPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1998-06-30
K981714 — TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEMAcromed Corp.·Product code MNH·1998-06-30
K981717 — STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORStryker Instruments·Product code FTD·1998-06-30
K981753 — INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSINGInnovative Technologies , Ltd.·Product code MGP·1998-06-30
K965223 — RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEMEndosonics Corp.·Product code IYO·1998-06-29
K974879 — MODEL 7410 VOYAGERHealthdyne Technologies, Inc.·Product code BZD·1998-06-29
K980170 — SURGITRONEllman Intl., Inc.·Product code GEI·1998-06-29
K980753 — CHROMOSCAN SCANNING SYSTEMMehl/Biophile Intl., Inc.·Product code GEX·1998-06-29
K980836 — GENIE CUP INTEGRATED SCREENING DEVICEApplied Technology Ventures, LLC·Product code LDJ·1998-06-29
K980887 — ELECSYS CEA ON THE ELECSYS 1010Boehringer Mannheim Corp.·Product code DHX·1998-06-29
K980915 — VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMValleylab, Inc.·Product code FYD·1998-06-29
K981149 — LASETTE LASER SKIN PERFORATORCell Robotics, Inc.·Product code GEX·1998-06-29
K981219 — OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGESEnable Medical Corp.·Product code GEI·1998-06-29
K981243 — BIOSTRIDE FREE T4 EIA TEST KITBiostride Diagnostics, Inc.·Product code CEC·1998-06-29
K981291 — VANTAGE 3.0 INSYNCHAdac Laboratories·Product code KPS·1998-06-29
K981320 — DAUM BONE BIOPSY SETDaum Corp.·Product code KNW·1998-06-29
K981342 — ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYAbbott Laboratories·Product code GKZ·1998-06-29
K981362 — SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORSynthes (Usa)·Product code DZL·1998-06-29
K981386 — MANAN BLUNT NEEDLEManan Medical Products, Inc.·Product code FPA·1998-06-29

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