FDA 510(k) clearances — page 709

176,637 clearances on record, most recent first.

Clearances — page 709

70,801–70,900 of 176,637

K033760 — ONE COAT SE BONDColtene/Whaledent, Inc.·Product code KLE·2004-01-23
K022908 — POSTERIOR CABLE SCREWPioneer Surgical Technology·Product code MNI·2004-01-22
K024252 — MATCH MASTER LOW FUSION PORCELAINDavis Schottlander & Davis, Ltd.·Product code EIH·2004-01-22
K030876 — CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEMCynosure, Inc.·Product code ISA·2004-01-22
K031621 — HERO 1, MODEL LY-ESB220Comfort Orthopedic Co., Ltd.·Product code IPL·2004-01-22
K031841 — SPACER G TEMPORARY HIP PROSTHESISExactech, Inc.·Product code KWL·2004-01-22
K032101 — POWERSTAND STAND-UP WHEELCHAIRThe Standing Co., Inc.·Product code IPL·2004-01-22
K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368Dako A/S·Product code JZG·2004-01-22
K033019 — SUNPEX TECHNOLOGIES MODEL SE03Sunpex Technology Co., Ltd.·Product code INI·2004-01-22
K033403 — T.S. MEDICAL CIRCUMCISION CLAMPT.S. Medical·Product code HFX·2004-01-22
K033515 — HUBERPRO SAFETY HUBER INFUSION SETCommand Medical Products·Product code FPA·2004-01-22
K033835 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLORMdm Enterprise Corp.·Product code LYZ·2004-01-22
K033908 — N HIGH SENSITIVITY CRPDade Behring, Inc.·Product code NQD·2004-01-22
K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTVysis·Product code MMW·2004-01-22
K033989 — MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69Medtronic Inc. Cardiac Rhythm Management·Product code DQY·2004-01-22
K033991 — MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SETPall Medical·Product code HIF·2004-01-22
K040028 — CA-1500R2 Technology, Inc.·Product code LLZ·2004-01-22
DEN040001 — CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEMAdvanced Diagnostic Systems·Product code NQI·2004-01-21
K031321 — LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001Medlogic Global Limited·Product code KMF·2004-01-21
K031686 — AEROMIST LT, MODEL HCS15004Medline Industries, Inc.·Product code BTI·2004-01-21
K031860 — SK MED ME202 MONITORING MIXERSk Med·Product code BZR·2004-01-21
K032511 — INTUITION IMAGEBrainlab AG·Product code LHN·2004-01-21
K033176 — TRISTAR AESTHETIC WORKSTATION LASERCynosure, Inc.·Product code GEX·2004-01-21
K033409 — AMERSHAM HEALTH NEEDLE-GUARDGettig Pharmaceutical Instrument Co.·Product code FMI·2004-01-21
K033632 — VARIFLEXGreat Lakes Orthodontics, Ltd.·Product code EBI·2004-01-21
K033865 — IDEIA PCE CHLAMYDIADakocytomation, Ltd.·Product code LJC·2004-01-21
K034019 — POLY PER-Q-CATH PICC CATHETERSC.R. Bard, Inc.·Product code LJS·2004-01-21
K034020 — GROSHONG NXT PICC CATHETERSC.R. Bard, Inc.·Product code LJS·2004-01-21
K034031 — 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGEM.K. Meditech Co. , Ltd.·Product code MEG·2004-01-21
K034040 — ESPRIT VENTILATOR, MODEL V1000Respironics, Inc.·Product code CBK·2004-01-21
K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IDiagnostic Products Corp.·Product code JHX·2004-01-21
K040015 — MODIFICATION TO PRISMALIX SURGICAL LIGHTAlm S.A.·Product code FSY·2004-01-21
K032604 — GII SPINAL FIXATION SYSTEMCo-Ligne AG·Product code MNH·2004-01-20
K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEMPortland Orthopaedics Pty. , Ltd.·Product code MEH·2004-01-20
K032799 — NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERReichert, Inc.·Product code HKX·2004-01-20
K033437 — SPHINX LASER SYSTEMSAllmed Systems, Inc.·Product code GEX·2004-01-20
K033476 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEMHowmedica Osteonics Corp.·Product code KTT·2004-01-20
K033507 — MRJParamed S.R.L.·Product code LNH·2004-01-20
K033744 — AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISAHycor Biomedical , Ltd.·Product code MVM·2004-01-20
K033902 — ONTRAK TESTCUP II AND ONSITE CUPKITVarian, Inc.·Product code DKZ·2004-01-20
K033956 — MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)Is2 Research, Inc.·Product code KPS·2004-01-20
K040018 — EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412Boston Scientific Corp·Product code EOQ·2004-01-20
K030341 — MODIFICATION TO INSPIRATION VENTILATOR SYSTEMeVent Medical, Ltd.·Product code CBK·2004-01-16
K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETERMediplus , Ltd.·Product code KLA·2004-01-16
K032124 — DUREX PLAY LUBRICANTSsl Americas, Inc.·Product code HIS·2004-01-16
K032303 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Instruments·Product code HBE·2004-01-16
K033227 — LUXAFORM PLUSDmg USA, Inc.·Product code EBG·2004-01-16
K033328 — NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENTNovosci Corp.·Product code DTL·2004-01-16
K033331 — CANDELA CBEAM PULSE DYE LASER SYSTEMCandela Corp.·Product code GEX·2004-01-16
K033344 — LIGAND PLUS CONTROL LEVEL 1-3Consolidated Technology·Product code JJY·2004-01-16
K033363 — ZIMMER UNICOMPARTMENTAL KNEE SYSTEMZimmer, Inc.·Product code HSX·2004-01-16
K033461 — CANDELA VBEAM PULSE DYE LASER SYSTEMCandela Corp.·Product code GEX·2004-01-16
K033521 — BISBLOCKBisco, Inc.·Product code EJK·2004-01-16
K033585 — DIAPEXBisco, Inc.·Product code KIF·2004-01-16
K033628 — ARTICHeraeus Kulzer, Inc.·Product code ELM·2004-01-16
K033658 — E.P.T. PREGNANCY TESTUnipath , Ltd.·Product code LCX·2004-01-16
K033692 — POWDERED VINYL EXAMINATION GLOVESShen Wei (Usa), Inc.·Product code LYZ·2004-01-16
K033693 — POWDER-FREE VINYL EXAMINATION GLOVESShen Wei (Usa), Inc.·Product code LYZ·2004-01-16
K033726 — PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETERPrecision Vascular·Product code KRA·2004-01-16
K033877 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOROne Touch Products Co., Ltd.·Product code LYZ·2004-01-16
K033903 — MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,Cook Urological, Inc.·Product code MQH·2004-01-16
K033904 — PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)Cook Urological, Inc.·Product code MQH·2004-01-16
K033915 — MODIFICATION TO SERAQUEST EB VCA IGGQuest Intl., Inc.·Product code LSE·2004-01-16
K024185 — BIODHOCFuture Medical Systems, SA·Product code HTY·2004-01-15
K030267 — EEG MONITOR WITH BIS, MODEL A-2000Aspect Medical Systems, Inc.·Product code OLW·2004-01-15
K031128 — B-SMART, MODEL B-01Macosta Medical USA, LLC·Product code CAZ·2004-01-15
K032108 — SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)Aesculap, Inc.·Product code MBH·2004-01-15
K032891 — TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KITTrans1, Inc.·Product code HRX·2004-01-15
K033279 — GOLD DENTAL CASTING ALLOYSBego U.S.A.·Product code EJT·2004-01-15
K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCESpecialities Remeex International, S.L.·Product code OTN·2004-01-15
K033342 — SCORPIO KNEE SYSTEM - TIBIAL INSERTSHowmedica Osteonics Corp.·Product code JWH·2004-01-15
K033376 — UGYTEX MESHSofradim Production·Product code FTL·2004-01-15
K033406 — SMALL BONE FIXATION SYSTEMHand Innovations, Inc.·Product code HTY·2004-01-15
K033423 — REVOLIX LASER SYSTEMSAllmed Systems, Inc.·Product code GEX·2004-01-15
K033432 — LEXATITE QUICK ACRYLICImtec Corp.·Product code EBG·2004-01-15
K033455 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5Biomedical Life Systems, Inc.·Product code GZJ·2004-01-15
K033462 — EARLY CLEAVAGE MEDIUM (ECM)Irvine Scientific Sales Co., Inc.·Product code MQL·2004-01-15
K033472 — TESCERA U-BAR AND BARRELSBisco, Inc.·Product code EBI·2004-01-15
K033483 — KLS-MARTIN ORTHO ANCHORAGE SYSTEMKLS-Martin L.P.·Product code DZE·2004-01-15
K033513 — EASI ECG ALGORITHMPhilips Medical Systems·Product code DRW·2004-01-15
K033639 — ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEMAcumed, LLC·Product code HWC·2004-01-15
K033654 — FORCE FIBERTeleflex Medical·Product code GAT·2004-01-15
K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbH·Product code KOJ·2004-01-15
K033773 — CONCEPT HP ADD-ON; CONCEPT HP ENAMELIvoclar Vivadent, AG·Product code EBF·2004-01-15
K033780 — MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.·Product code LJN·2004-01-15
K033815 — BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENGeistlich-Pharma·Product code NPM·2004-01-15
K033890 — ADVANCE DOUBLE HIGH INSERTWrightmedicaltechnologyinc·Product code JWH·2004-01-15
K033927 — ARTHOSCOPY PUMP A115W.O.M. World of Medicine AG·Product code HRX·2004-01-15
K033964 — SOLAR 9500 INFORMATION MONITORGe Medical Systems Information Technologies·Product code MHX·2004-01-15
K034002 — GAMMA3 NAIL SYSTEMHowmedica Osteonics Corp.·Product code HSB·2004-01-15
K034023 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1Microlife Intellectual Property GmbH·Product code FLL·2004-01-15
K034065 — MODIFICATION TO X-PORT DUO PORTC.R. Bard, Inc.·Product code LJT·2004-01-15
K030739 — INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGEInfusion Dynamics, Inc.·Product code FRN·2004-01-14
K031896 — NASAL-AIR CRITICAL CAREInnomed Technologies·Product code MNS·2004-01-14
K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)Med2000 S.R.L.·Product code CAF·2004-01-14
K032245 — ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239Arthrex, Inc.·Product code GAT·2004-01-14
K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBERTrudell Medical Intl.·Product code CAF·2004-01-14
K033087 — ORACLE ORAL MASK, MODEL HC451AFisher & Paykel Healthcare, Ltd.·Product code BZD·2004-01-14
K033557 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVEBecton, Dickinson & CO·Product code LON·2004-01-14
K033560 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELSBecton, Dickinson & CO·Product code LON·2004-01-14

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