FDA 510(k) clearances — page 693

176,637 clearances on record, most recent first.

Clearances — page 693

69,201–69,300 of 176,637

K040362 — DIAPHARMA FACTOR X KITDiapharma Group, Inc.·Product code GJT·2004-07-12
K041153 — SHARPSAWAY II LOCKING DISPOSABLE CUPArrow Intl., Inc.·Product code FMI·2004-07-12
K041413 — XPS 3000 SYSTEMMedtronic Xomed, Inc.·Product code ERL·2004-07-12
K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant Corporation·Product code DTD·2004-07-12
K040266 — CORE NEEDLE BIOPSYRemington Medical, Inc.·Product code KNW·2004-07-09
K040281 — LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)DePuy Orthopaedics, Inc.·Product code JWH·2004-07-09
K040999 — TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)Procter & Gamble Co.·Product code HEB·2004-07-09
K041293 — BIOPORE BALLOON DILATION CATHETERBipore, Inc.·Product code LIT·2004-07-09
K041321 — VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEMRichard Wolf Medical Instruments Corp.·Product code HET·2004-07-09
K041391 — FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVESHartalega Sdn Bhd·Product code LZA·2004-07-09
K041454 — KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13AKyphon, Inc.·Product code HRX·2004-07-09
K041586 — PROFEMUR S HIP STEMWrightmedicaltechnologyinc·Product code JDL·2004-07-09
K041645 — DDS-ZRCharles Scharf·Product code EIH·2004-07-09
K041738 — BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)Baxter Healthcare Corporation·Product code FRN·2004-07-09
K031454 — ACUMEN SURGICAL NAVIGATION SYSTEMBiomet, Inc.·Product code HAW·2004-07-08
K031701 — OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMOsteomed LP·Product code NEI·2004-07-08
K040439 — MDI TRIGGER GUARDNorth American Technical Services (Nats) Corp.·Product code CAF·2004-07-08
K040841 — POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)Medline Industries, Inc.·Product code LZA·2004-07-08
K040961 — INJECTOR NEEDLE/SNAREUnited States Endoscopy Group, Inc.·Product code FDI·2004-07-08
K040970 — LEONARDOSiemens Medical Systems, Inc.·Product code LLZ·2004-07-08
K041029 — KINETDXSiemens Medi Cal Solutions, Inc.·Product code LLZ·2004-07-08
K041350 — SYNTHES (USA) CHRONOSSynthes (Usa)·Product code GXP·2004-07-08
K041414 — CRONO AND CRONO, MODEL 30Cane S.R.L.·Product code FRN·2004-07-08
K041622 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEMDraeger Medical, Inc.·Product code BSZ·2004-07-08
K041688 — GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04General Electric Co.·Product code IYN·2004-07-08
K031140 — WATERLASEBiolase Technology, Inc.·Product code GEX·2004-07-07
K033488 — CMI MAGNETOCARDIOGRAPHCmi Cardiomag Imaging, Inc.·Product code DPS·2004-07-07
K033679 — COPSIOS BONE VOID FILLER (BVF)Centerpulse Spine-Tech, Inc.·Product code MQV·2004-07-07
K033926 — HOURGLASS VERTEBRAL BODY SPACERMedtronic Sofamor Danek·Product code MQP·2004-07-07
K040007 — INTERFERENTIAL STIMULATOR, MODEL BMLS02-6Biomedical Life Systems, Inc.·Product code LIH·2004-07-07
K040237 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTSIntuitive Surgical, Inc.·Product code NAY·2004-07-07
K040988 — ZIRCON-F PROPHYLAXIS PASTEPascal Co., Inc.·Product code EJR·2004-07-07
K041013 — SUILE OINTMENT WOUND DRESSINGHedonist Biochemical Technologies Co., Ltd.·Product code FRO·2004-07-07
K041020 — CADSTREAM VERSION 3.1Confirma, Inc.·Product code LNH·2004-07-07
K041101 — MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 24001Medical Adhesiveonline, LLC·Product code EGJ·2004-07-07
K041140 — ACELL UBM SURGICAL MESH ML AND MLPLUSAcell, Inc.·Product code FTM·2004-07-07
K041243 — DOVER RED RUBBER ROBINSON CATHETERTyco Healthcare·Product code KOD·2004-07-07
K041551 — MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc.·Product code HCG·2004-07-07
K041582 — MODIFICATION TO TRIPTER X-1 COMPACT DUETDirex Systems Corp.·Product code LNS·2004-07-07
K041584 — KYPHX HV-R BONE CEMENT, MODEL C01AKyphon, Inc.·Product code NDN·2004-07-07
K041606 — EXTRACTOR RX RETRIEVAL BALLOONBoston Scientific Corp·Product code FGE·2004-07-07
K041608 — C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENSUnilens Corp., USA·Product code LPL·2004-07-07
K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENTEncore Orthopedics, Inc.·Product code MBH·2004-07-06
K033953 — OPTIMESH 500E CEMENT RESTRICTORSpineology, Inc.·Product code JDK·2004-07-06
K040459 — TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLSBiosite Incorporated·Product code JJY·2004-07-06
K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPSPolymer Technology Systems, Inc.·Product code MRR·2004-07-06
K040935 — EBI XFIX DFS SYSTEMEbi, L.P.·Product code KTT·2004-07-06
K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600Alaris Medical Systems, Inc.·Product code FRN·2004-07-06
K041561 — LIQUICHEK WHOLE BLOOD VOLATILES CONTROLBio-Rad·Product code DIF·2004-07-06
K041670 — BIS PEDIATRIC SENSORAspect Medical Systems, Inc.·Product code GXY·2004-07-06
K033949 — VARILUX VISIONPRINT SYSTEM (VPS)Essilor Intl.·Product code HLL·2004-07-02
K040416 — SONICARE ADVANCE TOOTHBRUSH, MODEL 4900Philips Oral Healthcare, Inc.·Product code JEQ·2004-07-02
K040498 — MYSHELLSedat S.A.·Product code DTL·2004-07-02
K040930 — ZILVER BILIARY STENT SYSTEM USWWilson-Cook Medical, Inc.·Product code FGE·2004-07-02
K041004 — ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE)Purna Bina Sdn Bhd·Product code LYY·2004-07-02
K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796Pharmacia Deutschland GmbH·Product code MOB·2004-07-02
K041133 — MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERBayer Healthcare, LLC·Product code CDD·2004-07-02
K041325 — DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREEEst International Corporation·Product code LYZ·2004-07-02
K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERDeroyal·Product code EYC·2004-07-02
K041424 — NXSTAGE SYSTEM ONENxstage Medical, Inc.·Product code KDI·2004-07-02
K041552 — GE VIVID 7 BT04General Electric Co.·Product code IYN·2004-07-02
K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEMStockert Instrumente GmbH·Product code DTW·2004-07-02
K041576 — SOURCELINKC.R. Bard, Inc.·Product code KXK·2004-07-02
K041636 — H&S-CONDUCTIVITY STANDARD SOLUTIONH & S Technical Services·Product code FKH·2004-07-02
K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520Geister Medizin Technik GmbH·Product code MGZ·2004-07-01
K032937 — NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500Stereotaxis, Inc.·Product code DXX·2004-07-01
K033826 — ORTHOPEDIC ALLIANCE SPINE SYSTEMOrthopedic Alliance, LLC·Product code MNI·2004-07-01
K033951 — RADIX CERVICAL PLATEPisharodi Surgicals, Inc.·Product code KWQ·2004-07-01
K033959 — LPSDepuy, Inc.·Product code JWH·2004-07-01
K040096 — SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMSpinal Concepts, Inc.·Product code KWP·2004-07-01
K040155 — PERIPHERAL CUTTING BALLOONBoston Scientific Corp·Product code PNO·2004-07-01
K040438 — POWERHEART AED G3ACardiac Science, Inc.·Product code MKJ·2004-07-01
K040576 — MICROMESAM BASIC-SETMap Medizintechnik Fur Arzt Und Patient GmbH·Product code MNR·2004-07-01
K040907 — ARTHREX SMALL FRAGMENT PLATES AND SCREWSArthrex, Inc.·Product code HRS·2004-07-01
K040932 — EASYNET BODY POSITION MODULECadwell Laboratories, Inc.·Product code LEL·2004-07-01
K040938 — RADIAL NAIL SYSTEMWrightmedicaltechnologyinc·Product code HRS·2004-07-01
K040946 — ANKYLOS DENTAL IMPLANT SYSTEMFriadent GmbH·Product code DZE·2004-07-01
K040986 — CADWELL LIMB MOVEMENT MODULECadwell Laboratories, Inc.·Product code LEL·2004-07-01
K041001 — OMEGA 2 SYSTEMHowmedica Osteonics Corp.·Product code KTT·2004-07-01
K041081 — FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESHand Innovations, Inc.·Product code KTT·2004-07-01
K041092 — FAST START TENS, MODEL FS 3001Vision Quest Industries, Inc.·Product code GZJ·2004-07-01
K041106 — REVISION KNEE SYSTEMSmith & Nephew, Inc.·Product code JWH·2004-07-01
K041209 — RESMED S8 PIONEER CPAP SYSTEMResmed, Ltd.·Product code BZD·2004-07-01
K041302 — REFUGE SOUND GENERATORMicro-Ear Technology, Inc.·Product code KLW·2004-07-01
K041446 — NASALCEASELes Laboratorires Brothier, S.A.·Product code EMX·2004-07-01
K041449 — SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEATInterpore Cross Intl.·Product code KWP·2004-07-01
K041459 — LIFEPAK 12 DEFIBRILLATOR/MONITORMedtronic Emergency Response Systems, Inc.·Product code MKJ·2004-07-01
K041460 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code KWQ·2004-07-01
K041466 — TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)Biomet Manufacturing Corp·Product code JWH·2004-07-01
K041494 — OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2Olympus Corporation·Product code FET·2004-07-01
K041556 — MODIFICATION TO VERTE-STACK SPINAL SYSTEMMedtronic Sofamor Danek·Product code MQP·2004-07-01
K041641 — DAVOL DELIVERY SYSTEMC.R. Bard, Inc.·Product code GCJ·2004-07-01
K041656 — MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTDePuy Orthopaedics, Inc.·Product code LOD·2004-07-01
K041681 — ATRICURE DISSECTORAtriCure, Inc.·Product code FTD·2004-07-01
K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGETyco Healthcare·Product code NGT·2004-06-30
K033174 — BMLS03-3Biomedical Life Systems, Inc.·Product code IPF·2004-06-30
K033355 — LACTOSCREW SCREW ANCHORBiomet Orthopedics, Inc.·Product code HWC·2004-06-30
K033402 — PORTABLE SLEEP DATA RECORDER (PSDR)Pro-Tech Services, Inc.·Product code MNR·2004-06-30
K033984 — STRAUMANN DENTAL IMPLANT SYSTEMInstitut Straumann AG·Product code DZE·2004-06-30
K034043 — H-FLOW VALVEElcam Medical Acal·Product code DQO·2004-06-30

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