FDA 510(k) clearances — page 402

176,542 clearances on record, most recent first.

Clearances — page 402

40,101–40,200 of 176,542

K132996 — CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTSIsoray, Inc.·Product code KXK·2013-12-17
K133079 — IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)Alden Optical Labs., Inc.·Product code LPL·2013-12-17
K133188 — MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINALStryker Spine·Product code NKB·2013-12-17
K133243 — OPTION ELITE VENA CAVA FILTER SYSTEMRex Medical, L.P.·Product code DTK·2013-12-17
K133246 — ZIMMER DISTAL RADIUS PLATING SYSTEMZimmer, Inc.·Product code HRS·2013-12-17
K133291 — ST360 DEGREES SPINAL FIXATION SYSTEMZimmer Spine, Inc.·Product code NKB·2013-12-17
K133342 — ARTHREX IBALANCE TKA SYSTEMArthrex, Inc.·Product code JWH·2013-12-17
K123678 — HYALMIX CREAMIgi Laboratories, Inc.·Product code FRO·2013-12-16
K130073 — MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODSMikron Makina Sanayi VE Ticaret Ltd. Sti.·Product code MNI·2013-12-16
K131060 — CLEARGUARD HD END CAPPursuit Vascular, Inc.·Product code PEH·2013-12-16
K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAYSynthes, Inc.·Product code GXQ·2013-12-16
K131952 — CORIN METAFIX HIP STEMCorin USA·Product code LZO·2013-12-16
K131986 — CORIN MINIHIP STEMCorin USA·Product code LZO·2013-12-16
K132147 — 2D PERFUSIONPhilips Medical Systems Nederland B.V.·Product code OWB·2013-12-16
K132240 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIESGrandway Technology (Shenzhen) Limited·Product code DXN·2013-12-16
K132253 — REMOVABLE PATIENT LEADS ECG CABLEBoston Scientific·Product code DSA·2013-12-16
K132522 — HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLEEthicon Endo-Surgery, LLC·Product code LFL·2013-12-16
K132618 — ONETOUCH REVEALLifescan, Inc.·Product code MRZ·2013-12-16
K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.·Product code DIF·2013-12-16
K132785 — STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITYStryker Endoscopy·Product code GCJ·2013-12-16
K132910 — DEPUY SYNTHES SPINE DENS ACCESS SYSTEMSynthes USA Products, LLC·Product code HWC·2013-12-16
K132963 — FUSIONSYNC, CHIMAERA FUSIONSYNCChimaera GmbH·Product code LLZ·2013-12-16
K133305 — RHYTHM VIEW WORKSTATIONTopera, Inc.·Product code DQK·2013-12-16
K133454 — SONOSITE EDGE ULTRASOUND SYSTEMFUJIFILM Sonosite, Inc.·Product code IYN·2013-12-16
DEN130022 — NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOREneura Therapeutics·Product code OKP·2013-12-13
K121248 — LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTACMoller Medical GmbH·Product code JXG·2013-12-13
K122035 — HEPAFAT SCANResonance Health Analysis Services Pty, Ltd.·Product code LNH·2013-12-13
K130704 — MICRODOSE SIPhilips Digital Mammography Sweden AB·Product code MUE·2013-12-13
K130738 — ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITSNanjing Maidixin Medical Device Co., Ltd.·Product code GDW·2013-12-13
K130913 — GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEMGenesys Spine·Product code MAX·2013-12-13
K131979 — PROVANT THERAPY SYSTEMRegenesis Biomedical, Inc.·Product code ILX·2013-12-13
K131996 — S-SCANEsaote, S.p.A.·Product code LNH·2013-12-13
K132015 — TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORSSmith & Nephew, Inc.·Product code HIH·2013-12-13
K132060 — DURABLUE STERILIZATION WRAPCardinal Health-Medical Products and Services·Product code FRG·2013-12-13
K132441 — BARD VENTRALEX HERNIA PATCHC.R. Bard, Inc.·Product code FTL·2013-12-13
K132484 — DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILEWrp Asia Pacific Sdn. Bhd.·Product code LZA·2013-12-13
K132594 — CROSSCHECK PLATING SYSTEMSolana Surgical, LLC·Product code HRS·2013-12-13
K133035 — NORMED PELLEGRIN CALCANEUS STOP SCREWNormed Medizin-Technik GmbH·Product code HWC·2013-12-13
K123861 — AIDI DENTAL IMPLANT SYSTEMAidi Biomedical, LLC·Product code DZE·2013-12-12
K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGChongqing Psk Sci-Tech Development Co., Ltd.·Product code DRN·2013-12-12
K131766 — PLATINUM DRF IMAGING SYSTEMApelem-Dms Group·Product code JAA·2013-12-12
K132120 — WTF SECURA SYRINGE AND NEEDLEBeijing Wantefu Medical Apparatus Co., Ltd.·Product code FMF·2013-12-12
K132177 — MEDCOMP GEN III POWER INJECTABLE PORTMedcomp ( Medical Components)·Product code LJT·2013-12-12
K132523 — MYOPERFUSIONToshibamedical Systems Corporation·Product code JAK·2013-12-12
K132558 — SYNC-RX SYSTEMVolcano Corporation·Product code OWB·2013-12-12
K132754 — NEOGEN PSR SYSTEMEnergist, Ltd.·Product code GEI·2013-12-12
K132803 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINKMedapps Inc., Dba Alere Connect·Product code DRG·2013-12-12
K132862 — HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.·Product code NBW·2013-12-12
K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDatascope Corp.·Product code DSP·2013-12-12
K133230 — INQWIRE DIAGNOSTIC GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2013-12-12
K133435 — MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13ASiemens Medical Solutions USA, Inc.·Product code LNH·2013-12-12
K121873 — AVINENT DENTAL IMPLANT SYSTEMAvinent Implant System S.L.·Product code DZE·2013-12-11
K122834 — POLYSITE IMPLANTABLE INFUSION PORTSPerouse Medical·Product code LJT·2013-12-11
K123728 — RETRIEVAL BAGFlexbar Machine Corp.·Product code GCJ·2013-12-11
K130317 — GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEMGenesys Spine·Product code ODP·2013-12-11
K130708 — SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKSSmith & Nephew, Inc.·Product code JWH·2013-12-11
K130758 — KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDERKronner Prototypes, Inc.·Product code LKF·2013-12-11
K131596 — WOUND MEASURING & MONITORING DEVICEWoundvision, LLC·Product code FXN·2013-12-11
K131649 — MESyneron Beauty , Ltd.·Product code ONF·2013-12-11
K132028 — ULTHERA SYSTEMUlthera, Inc.·Product code OHV·2013-12-11
K132773 — SIDEXIS 4Sirona Dental Systems GmbH·Product code LLZ·2013-12-11
K132873 — VANGUARD XP KNEE SYSTEMBiomet, Inc.·Product code MBH·2013-12-11
K132897 — CLYDESDALE SPINAL SYSTEMMedtronic Sofamor Danek, Inc.·Product code MAX·2013-12-11
K133094 — CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.·Product code KWP·2013-12-11
K133180 — ERBE ESU MODEL VIO DV WITH ACCESSORIESErbe USA, Inc.·Product code GEI·2013-12-11
K133687 — THD N-ANO ANOSCOPEThd Spa·Product code FER·2013-12-11
K122393 — TG-BODY MI&BODY S-TRAINERMiga Medical Co., Ltd.·Product code NGX·2013-12-10
K123248 — CPR RSQ ASSISTAvantech, Inc.·Product code LIX·2013-12-10
K131586 — CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.·Product code HCC·2013-12-10
K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMMako Surgical Corporation·Product code NPJ·2013-12-10
K133474 — BIOSIGN FLU A + B, STATUS FLU A & BPrinceton BioMeditech Corp.·Product code PSZ·2013-12-10
K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.·Product code MEA·2013-12-09
K130861 — MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)Dako North America, Inc.·Product code MXZ·2013-12-09
K132532 — SYNGO.PLAZA VB10ASiemens AG Healthcare·Product code LLZ·2013-12-09
K132775 — PONTO PLUS AND PONTO PLUS POWEROticon Medical AB·Product code LXB·2013-12-09
K132783 — EXOSHAPE DUO SOFT TISSUE FASTENERMedShape, Inc.·Product code MBI·2013-12-09
K133016 — VENT-OS SINUS DILATION SYSTEMSinusys Corporation·Product code LRC·2013-12-09
K133126 — K7 LUMBAR SPACERSK7, LLC·Product code MAX·2013-12-09
K133289 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.·Product code HSB·2013-12-09
K130004 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEMBoston Scientific Corporation·Product code ESW·2013-12-06
K130669 — SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPSOlsen Medical·Product code GEI·2013-12-06
K131006 — ANESTHESIA CONDUCTION NEEDLESLccs Products Limited·Product code BSP·2013-12-06
K131550 — HEART SYNCHeart Sync, Inc.·Product code MKJ·2013-12-06
K131702 — K SERIES CPAP SYSTEMSCurative Medical, Inc.·Product code BZD·2013-12-06
K131851 — OSTEOMED NEURO RONGEUROsteomed·Product code HAE·2013-12-06
K132185 — FAMILY OF COOLGLIDE AESTHETIC LASERSCutera, Inc.·Product code GEX·2013-12-06
K132202 — DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINETEnthermics Medical Systems, Inc.·Product code LGZ·2013-12-06
K132242 — INNO SLA SUBMERGED IMPLANT SYSTEMCowellmedi Co., Ltd.·Product code DZE·2013-12-06
K132328 — CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code NKB·2013-12-06
K132395 — LIGAPASSMedicrea International·Product code OWI·2013-12-06
K132429 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETTerumobct, Inc.·Product code LKN·2013-12-06
K132445 — PIEZON 250E.M.S Electro Medical Systems S.A·Product code ELC·2013-12-06
K132519 — STRYKER CUSTOMIZED MANDIBLE RECON PLATE KITStryker·Product code JEY·2013-12-06
K132967 — 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP3B Medical, Inc.·Product code BZD·2013-12-06
K133029 — ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICECompression Works, LLC·Product code DXC·2013-12-06
K133043 — PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATUREAngioslide, Ltd.·Product code LIT·2013-12-06
K133207 — STAXX(R) SYSTEMSpine Wave, Inc.·Product code MQP·2013-12-06
K133356 — PROLENE POLYPROPYLENE NONABSORBABLE SUTUREETHICON, Inc.·Product code GAW·2013-12-06
K133372 — CROSSTREES PVA PODCrosstrees Medical, Inc.·Product code NDN·2013-12-06
K121177 — BOND APATITEAugma Biomaterials, Ltd.·Product code LYC·2013-12-05

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