FDA 510(k) clearances — page 721

176,637 clearances on record, most recent first.

Clearances — page 721

72,001–72,100 of 176,637

K032709 — MODULAR PLUS HIP STEMPlus Orthopedics·Product code LWJ·2003-09-23
K032769 — EYESOPEN TONOMETEREye-Deas, LLC·Product code HKY·2003-09-23
K032771 — MEDRAD CONTINUUM MR INFUSION SYSTEMMedrad, Inc.·Product code FRN·2003-09-23
K032773 — DIAMOND D HIGH IMPACT DENTURE ACRYLICMycone Dental Supply Co., Inc.·Product code EBI·2003-09-23
K032833 — MYOSYSTEM WITH CUSTOMIZINGOtto Bock Healthcare LP·Product code GXY·2003-09-23
K023983 — MODIFICATION TO HIGHGATE CURVED ROD SYSTEMHighgate Orthopaedics·Product code KWQ·2003-09-22
K024125 — HALM ZIELKE INSTRUMENTATION SYSTEMMicomed Ortho GmbH·Product code KWQ·2003-09-22
K030867 — ESKA MODULAR HIP SYSTEM CEMENTEDEska Implants GmbH·Product code JDI·2003-09-22
K031280 — ULTRA-DRIVE 3Biomet, Inc.·Product code JDX·2003-09-22
K031604 — GLYCOMARKTomen America, Inc.·Product code NOZ·2003-09-22
K031889 — ALEXIS WOUND RETRACTORApplied Medical Resources Corp.·Product code KKX·2003-09-22
K031945 — ARTHREX TRIMIT SCREW, MODEL AR-4161BArthrex, Inc.·Product code HWC·2003-09-22
K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEETMacropore Biosurgery, Inc.·Product code FTL·2003-09-22
K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.·Product code MMP·2003-09-22
K032110 — PROCLASS PRESS FIT HIP STEMStelkast Company·Product code LWJ·2003-09-22
K032169 — CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)Cyberorthology, Inc.·Product code LXT·2003-09-22
K032187 — ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEMArthrex, Inc.·Product code HRS·2003-09-22
K032299 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/MLBecton, Dickinson & CO·Product code LON·2003-09-22
K032380 — WAGNER CONE PROSTHESISCenterpulse Orthopedics, Inc.·Product code LZO·2003-09-22
K032510 — ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TESTACON Laboratories, Inc.·Product code LCX·2003-09-22
K032778 — LARGE VOLUME FLUID RESERVOIRBelmont Instrument Corp.·Product code LGZ·2003-09-22
K023758 — BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)Fci Ophthalmics, Inc.·Product code OKS·2003-09-17
K030145 — GALIX WINTERGalix Biomedical Instrumentation, Inc.·Product code DQK·2003-09-17
K030180 — CRESCENT TINNITUS RETAINING SOUND GENERATORStarkey Laboratories, Inc.·Product code KLW·2003-09-17
K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBEPortex , Ltd.·Product code BTO·2003-09-17
K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.·Product code HGP·2003-09-17
K030815 — AKERS LABORATORIES INC. BLOOD CELL SEPARATORAkers Laboratories, Inc.·Product code JKA·2003-09-17
K030821 — SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5Simuplan S.L.·Product code MUJ·2003-09-17
K030832 — PRIMOSPLINT SYSTEMCosmedent, Inc.·Product code MQC·2003-09-17
K030836 — D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGEVascular Solutions, Inc.·Product code QSX·2003-09-17
K031099 — SORB+HISORB+CARTRIDGERenal Solutions, Inc.·Product code FKT·2003-09-17
K031351 — FLEX-NECK PD CATHETER, INFANTMedigroup, Inc.·Product code FJS·2003-09-17
K031855 — SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEMSpinal Concepts, Inc.·Product code KWQ·2003-09-17
K031902 — ONLINE TDM CARBAMAZEPINERoche Diagnostics Corp.·Product code KLT·2003-09-17
K031925 — PROCEED TRILAMINATE SURGICAL MESHETHICON, Inc.·Product code FTL·2003-09-17
K031967 — TSRH SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code MNI·2003-09-17
K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCAREIbp Instruments GmbH·Product code FKH·2003-09-17
K032137 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMCordis Corp.·Product code FGE·2003-09-17
K032267 — R&D DESIGNATION AP-052-5Jensen Industries, Inc.·Product code EJT·2003-09-17
K032269 — SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATESSynthes (Usa)·Product code HRS·2003-09-17
K032495 — THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEMLifecore Biomedical, Inc.·Product code DZE·2003-09-17
K032567 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVEBecton, Dickinson & CO·Product code LON·2003-09-17
K032578 — TSRH SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code MNI·2003-09-17
K032582 — UNITY NETWORK PATIENT DATA SERVERGe Medical Systems Information Technologies·Product code MSX·2003-09-17
K032584 — RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629Rubicor Medical, Inc.·Product code GEI·2003-09-17
K032611 — LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743Bio-Rad·Product code GGN·2003-09-17
K032760 — APAX PACS SYSTEMTis, Inc.·Product code LLZ·2003-09-17
K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060Idev Technologies, Inc.·Product code MCW·2003-09-16
K030719 — PENTACAM SCHEIMPFLUG CAMERAOculus Optikgerate GmbH·Product code MXK·2003-09-16
K030846 — CANDELA SMOOTHBEAM LASER SYSTEMCandela Corp.·Product code GEX·2003-09-16
K031499 — DIOBEAM 830Soft-Core Texas, Inc.·Product code NHN·2003-09-16
K031593 — SOPRO 61DSopro·Product code GCJ·2003-09-16
K031632 — OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTSImplant Innovations, Inc.·Product code DZE·2003-09-16
K031933 — MEDLINE REUSABLE SURGICAL GOWNS (100X)Medline Industries, Inc.·Product code FYA·2003-09-16
K031948 — PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Pm Devices, Inc.·Product code DXZ·2003-09-16
K032165 — VINTAGE ALShofu Dental Corp.·Product code EIH·2003-09-16
K032529 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310Hydrocision, Inc.·Product code HRX·2003-09-16
K032542 — MODIFICATION TO CONTOUR SE MICROSPHERESBoston Scientific Corp·Product code HCG·2003-09-16
K032569 — SHORT INTRODUCER SHEATHRex Medical·Product code DYB·2003-09-16
K032615 — ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300Asahi Intecc Co., Ltd.·Product code DQX·2003-09-16
K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000Belmont Instrument Corp.·Product code LGZ·2003-09-16
K032749 — BEDSIDE MONITOR, MODEL OPV-1500Nihon Kohden America, Inc.·Product code MWI·2003-09-16
K023837 — LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMAPrinceton BioMeditech Corp.·Product code LAF·2003-09-15
K024148 — SALINUM, ORCLAIRSinclair Pharmaceuticals, Ltd.·Product code LFD·2003-09-15
K030614 — 3I DENTAL IMPLANTSImplant Innovations, Inc.·Product code DZE·2003-09-15
K031337 — ACUMEN SURGICAL NAVIGATION SYSTEMBiomet, Inc.·Product code HAW·2003-09-15
K031932 — FLUORIDE VARNISHDentsply Intl.·Product code LBH·2003-09-15
K031972 — ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,Asap Endoscopic Products GmbH·Product code HRX·2003-09-15
K031983 — INOVO, INC, ECONOMIZER CONSERVING REGULATORInovo, Inc.·Product code NFB·2003-09-15
K032054 — RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USERadionics, A Division of Tyco Healthcare Group LP·Product code HAW·2003-09-15
K032212 — KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17AKyphon, Inc.·Product code HRX·2003-09-15
K032431 — PRISMA M60/M100 SETSGambro, Inc.·Product code KDI·2003-09-15
K032518 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)Bd Diagnostic Systems·Product code JWY·2003-09-15
K032566 — NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMPThe First Years, Inc.·Product code HGX·2003-09-15
K030466 — HANDYDOPElcat, GmbH·Product code KNG·2003-09-12
K030522 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTIONCiba Vision Corporation·Product code LPN·2003-09-12
K030564 — THERMOSKIN CONDUCTIVE PADSUnited Pacific, Inc.·Product code GXY·2003-09-12
K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.·Product code LHD·2003-09-12
K031359 — S-MONOVETTE EDTA K2-GELSarstedt, Inc.·Product code PJE·2003-09-12
K032033 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek·Product code NKB·2003-09-12
K032150 — SAFETY-MULTIFLYSarstedt, Inc.·Product code FPA·2003-09-12
K032163 — DURACON TOTAL KNEE SYSTEMHowmedica Osteonics Corp.·Product code MBH·2003-09-12
K032229 — QUANTUM WARP 10 LIGHT DELIVERY SYSTEMQuantum Devices, Inc.·Product code ILY·2003-09-12
K032393 — INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)Elcam Medical Acal·Product code FMG·2003-09-12
K032538 — 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COILUsa Instruments, Inc.·Product code MOS·2003-09-12
K032541 — POLESTAR N-20Odin Medical Technologies , Ltd.·Product code LNH·2003-09-12
K032552 — ACCU-CHEK ADVANTAGE SYSTEMRoche Diagnostics Corp.·Product code NBW·2003-09-12
K032588 — MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)Disco-O-Tech Medical Technologies, Ltd.·Product code HSB·2003-09-12
K032618 — 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COILUsa Instruments, Inc.·Product code MOS·2003-09-12
K032652 — RS-4I MUSCLE STIMULATOR FAMILYRs Medical·Product code IPF·2003-09-12
K032653 — E275Micro Current Technology, Inc.·Product code GZJ·2003-09-12
K032754 — VORTEX MPHorizon Medical Products, Inc.·Product code LJT·2003-09-12
K022156 — LATEX ULTRASONIC PROBE COVERPleasure Latex Products Sdn. Bhd.·Product code ITX·2003-09-11
K022258 — B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEMB.T.I. Biotechnology Institute, Sl.·Product code DZE·2003-09-11
K031721 — COMPOSITE RESTORATION MATERIALMilton Hodosh, M.D.·Product code EBF·2003-09-11
K031801 — PANTOS, MODELS: PANTOS 16, AND PANTOS DGBlue X Imaging Srl·Product code MUH·2003-09-11
K031899 — QUICKVUE INFLUENZA A+B TESTQuidel Corp.·Product code PSZ·2003-09-11
K031951 — TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6Baylis Medical Co., Inc.·Product code GEI·2003-09-11
K031985 — SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMSpinal Concepts, Inc.·Product code MNI·2003-09-11
K032153 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/MLBd Diagnostic Systems·Product code LON·2003-09-11

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