FDA 510(k) clearances — page 469

176,542 clearances on record, most recent first.

Clearances — page 469

46,801–46,900 of 176,542

K110912 — SMART TOUCH UVTHERAPY MULTIPLE MACHINEDaavlin Distributing Co.·Product code FTC·2011-10-20
K110919 — CARESTREAM PACSCarestream Health, Inc.·Product code LLZ·2011-10-20
K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGSAdvanced Medical Products Sdn Bhd·Product code LZA·2011-10-20
K111155 — XTRAFIX EXTERNAL FIXATION SYSTEMExtraortho, Inc.·Product code KTT·2011-10-20
K111402 — KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODELKimberly-Clark·Product code FXX·2011-10-20
K111414 — QUANTA FLASH (TM) DGP SCREENInova Diagnostics, Inc.·Product code MST·2011-10-20
K111542 — DELTEX MEDICAL CARDIOQ EDMDeltex Medical Limited·Product code DPW·2011-10-20
K111587 — ALERKAN SPIROMETRY FILTERAlerkan, Ltd.·Product code BZG·2011-10-20
K111772 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILEKossan Latex Industries(M)Sdn Bhd·Product code LZA·2011-10-20
K112211 — DURA BLUE STERILIZATION WRAPCardinal Health200, LLC·Product code FRG·2011-10-20
K112267 — NEUROLAC(R) NERVE GUIDEPolyganics B.V.,·Product code JXI·2011-10-20
K112269 — OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPEOSTAR MEDITECH CORP.·Product code DXN·2011-10-20
K112283 — DURA BLUE STERILIZATION WRAPCardinal Health200, LLC·Product code FRG·2011-10-20
K112374 — X-TRA BASEVoco GmbH·Product code EBF·2011-10-20
K112468 — THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARERegulatory Specialists, Inc.·Product code KNW·2011-10-20
K112512 — VANISHPOINT BLOOD COLLECTION SETRetractable Technologies, Inc.·Product code FPA·2011-10-20
K112626 — LIPSONIX(R) SYSTEM MODEL 2Medicis Technologies Corporation·Product code OHV·2011-10-20
K112661 — VIZION DRViztek, LLC·Product code MQB·2011-10-20
K112737 — TIGER HEADLESS CANNULATED SCREWSTrilliant Surgical, Ltd.·Product code HWC·2011-10-20
K112744 — SAPIENS TIP CONFIRMATION SYSTEMC.R. Bard, Inc.·Product code LJS·2011-10-20
K112788 — EASTLYTE NA/K/CA/PHMedica Corp.·Product code CEM·2011-10-20
K112974 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMCurve Dental, Inc.·Product code LLZ·2011-10-20
K110345 — SCANVIEW SYSTEMApplied Spectral Imaging·Product code NTH·2011-10-19
K110804 — AMT G-J TUBEApplied Medical Technology, Inc.·Product code KNT·2011-10-19
K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMSIdev Technologies, Inc.·Product code FGE·2011-10-19
K112098 — TBDLensar, Inc.·Product code OOE·2011-10-19
K110021 — DASH HIPBrainlab AG·Product code OLO·2011-10-18
K110716 — EVERYWAY LOW BACK PAIN RELIEF SYSTEMEveryway Medical Instruments Co.,Ltd·Product code NUH·2011-10-18
K111883 — SMARTLOC SPINAL FIXATION SYSTEMA-Spine Asia, Co., Ltd.·Product code MNI·2011-10-18
K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANArk Diagnostics, Inc.·Product code LAO·2011-10-18
K111909 — VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCEbioMerieux, Inc.·Product code LON·2011-10-18
K111979 — RADIOACTIVE SEED LOCALIZATION NEEDLEBiocompatibles, Inc.·Product code KXK·2011-10-18
K112323 — CARDIA-CATHMillar Instruments, Inc.·Product code DXO·2011-10-18
K112384 — ABDOMINAL TOURNIQUET SYSTEMCompression Works, LLC·Product code DXC·2011-10-18
K112528 — ELECSYS T4 CALCHECK 5Roche Diagnostics Corporation·Product code JJX·2011-10-18
K112586 — CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)Becton, Dickinson and Company (BD)·Product code JTN·2011-10-18
K112745 — V-14 CONTROL WIRE GUIDEWIREBoston Scientific Corporation·Product code DQX·2011-10-18
K112759 — APCLO PEDICLE SCREW SYSTEMSAtlas Spine, Inc.·Product code NKB·2011-10-18
K112893 — CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSBaxter Healthcare Corporation·Product code FPA·2011-10-18
K112929 — THERMOFLASH(TM) INFRARED THERMOMETERVisiomed Group SA·Product code FLL·2011-10-18
K103598 — PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDESWrightmedicaltechnologyinc·Product code MBH·2011-10-17
K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAAlcon Research, Ltd.·Product code HQB·2011-10-17
K111311 — SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURINGOmisa Inc. (Segasist Technologies)·Product code MUJ·2011-10-17
K111354 — GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)GS Medical Co., Ltd.·Product code MAX·2011-10-17
K111408 — MICROGARD IICarefusion Germany 234 GmbH·Product code CAH·2011-10-17
K111990 — CORONIS 5MPBarco N.V.·Product code LLZ·2011-10-17
K112014 — ZYSTON STRAIGHT SPACER SYSTEMBiomet Spine·Product code MAX·2011-10-17
K112032 — 8FR TURBO - TANDEM SYSTEMSpectranetics Corp.·Product code DQY·2011-10-17
K112156 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEMMedos International SARL·Product code JXG·2011-10-17
K112358 — UNIMAX TROCAR SYSTEMUnimax Medical Systems, Inc.·Product code GCJ·2011-10-17
K112439 — SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0Fujifilm Medical System U.S.A., Inc.·Product code LLZ·2011-10-17
K112710 — ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZRWieland Dental + Technik GmbH & Co. KG·Product code EIH·2011-10-17
K112874 — EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLC·Product code KCY·2011-10-17
K102346 — RANDOX DIGOXIN ASSAYRandox Laboratories, Ltd.·Product code KXT·2011-10-14
K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORSAbbott Laboratories·Product code KLT·2011-10-14
K103752 — VITEK 2 SYSTEMS (PC) 5.02 SOFTWAREbioMerieux, Inc.·Product code LON·2011-10-14
K110135 — POLARCUP DUAL MOBILITY SYSTEMSmith & Nephew, Inc.·Product code LPH·2011-10-14
K110250 — MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVESTotal Gloves Sdn Bhd·Product code LYY·2011-10-14
K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAYSiemens Healthcare Diagnostics, Inc.·Product code MRG·2011-10-14
K111120 — CSM SUBMERGED-R IMPLANT SYSTEMCsm Implant·Product code DZE·2011-10-14
K111436 — PORCINE SURGICAL MESH, PORCINE DERMAL MATRIXBrennen Medical, LLC·Product code FTM·2011-10-14
K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRYRespironics, Inc.·Product code CBK·2011-10-14
K111737 — DISPOSABLE ELECTRODESanibel Supply·Product code GXY·2011-10-14
K111910 — GLADIATOR HIP STEMWrightmedicaltechnologyinc·Product code KWA·2011-10-14
K111958 — TETRIC EVOCERAM BULK FILLIvoclar Vivadent, Inc.·Product code EBF·2011-10-14
K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACKKuraray Medical, Inc.·Product code KLE·2011-10-14
K111980 — CLEARFIL TRI-S BOND PLUSKuraray America, Inc.·Product code KLE·2011-10-14
K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGEMedrad, Inc.·Product code DXT·2011-10-14
K112370 — WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEMWelldoc, Inc.·Product code MRZ·2011-10-14
K112694 — EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETEREdwards Lifesciences, LLC·Product code DXC·2011-10-14
K112771 — BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGSorin Group Italia S.R.L.·Product code DTN·2011-10-14
K112773 — NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC·Product code MQV·2011-10-14
K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXVygon Corp.·Product code FPD·2011-10-13
K101774 — MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)Alcon Manufacturing, Ltd.·Product code MSS·2011-10-13
K103434 — 3B FLEX-LITE3B Products, LLC·Product code BZD·2011-10-13
K103757 — IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENTGrifols·Product code CFF·2011-10-13
K110003 — MTF NEW BONE VOID FILLERMusculoskeletal Transplant Foundation·Product code MQV·2011-10-13
K110407 — INVISIPORTStealth Therapeutics, Incorporated·Product code LJT·2011-10-13
K111492 — ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSMaterialise NV·Product code JWH·2011-10-13
K111597 — DISPOSABLE STIMULATING ELECTRODENuvasive, Inc.·Product code ETN·2011-10-13
K111978 — SULCUS BLUEProduits Dentaires Pierre Rolland·Product code MVL·2011-10-13
K103115 — PRODIGY DIABETES MANAGEMENT SOFTWAREProdigy Diabetes Care, LLC·Product code NBW·2011-10-12
K110153 — SFC VERTEBRAL BODY REPLACEMENTKonigsee Implantate GmbH·Product code MQP·2011-10-12
K110646 — BEAMMED SUNLIGHT MINIOMNI BONE SONOMETERBeam-Med, Ltd.·Product code MUA·2011-10-12
K110993 — FEMCHEC PRESSURE MANAGEMET DEVICEFemasys, Inc.·Product code LKF·2011-10-12
K111200 — MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEMGE Healthcare·Product code DQK·2011-10-12
K111264 — CORNERSTONE (R) PSR CERVICAL FUSION SYSTEMMedtronic Sofamor Danek USA·Product code ODP·2011-10-12
K111543 — VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.·Product code NOT·2011-10-12
K112019 — BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUPCorentec Co., Ltd.·Product code KWY·2011-10-12
K112051 — LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWAREBroncus Technologies, Inc.·Product code LLZ·2011-10-12
K112335 — BANTAM CATHETER (280MM BALLOON LENGTHS)ClearStream Technologies , Ltd.·Product code DQY·2011-10-12
K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMSamsung Medison Co., Ltd.·Product code IYN·2011-10-12
K102063 — HEALTH-E-CONNECT SYSTEMAlr Technologies·Product code NBW·2011-10-11
K110694 — CONCORDE BULLET SPINAL SYSTEMJohnson & Johnson·Product code MAX·2011-10-11
K111875 — RELIEVA SPIN SINUS DILATION SYSTEMAcclarent, Inc.·Product code LRC·2011-10-11
K111994 — SMITH & NEPHEW CANNULATED SCREWS AND WASHERSSmith & Nephew, Inc.·Product code HWC·2011-10-11
K112017 — RAUMEDIC ICP MONITORING SYSTEMRaumedic AG·Product code GWM·2011-10-11
K112254 — APEX KIRSCHNER WIRES AND STEINMANN PINSApex Tools & Orthopedics Co.·Product code HTY·2011-10-11
K112615 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.·Product code PHX·2011-10-11
K112629 — ONSET ACCESS CATHETER SYSTEMOnset Medical Corporation·Product code DQY·2011-10-11

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