FDA 510(k) clearances — page 423

176,542 clearances on record, most recent first.

Clearances — page 423

42,201–42,300 of 176,542

K123429 — OLYMPUS ENERGY POWER SYSTEM (EPS)Gyrus Acmi, Inc.·Product code GEI·2013-04-05
K123701 — HEARLAB ACAFrye Electronics, Inc.·Product code GWJ·2013-04-05
K123796 — NEURO OMEGA SYSTEMAlpha Omega Engineering , Ltd.·Product code GZL·2013-04-05
K123806 — FIBROSCANEchosens·Product code IYO·2013-04-05
K123892 — MEPILEX TRANSFER AGMolnlycke Health Care·Product code FRO·2013-04-05
K123961 — SENTREX BIOSPONGE MPDBionova Medical, Inc.·Product code KGN·2013-04-05
K124027 — MONSTER SCREW SYSTEMApogee Orthosolutions·Product code HWC·2013-04-05
K130006 — BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTSCook Biotech Incorporated·Product code PAI·2013-04-05
K130044 — SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEMWrightmedicaltechnologyinc·Product code KTT·2013-04-05
K130069 — INNOVA EPVISION 2.0, INNOVA EPVISION 2.0GE Healthcare·Product code LLZ·2013-04-05
K130237 — PONTIC PAINTReliance Orthodontic Products, Inc.·Product code NXC·2013-04-05
K130308 — NOBLUS ULTRASOUND DIAGNOSTIC SYSTEMHitachi Aloka Medical, Ltd.·Product code IYN·2013-04-05
K130340 — LOCKING BONE PLATES AND SCREWSWeigao Orthopaedic Device Co., Ltd.·Product code HRS·2013-04-05
K130400 — MERETEC CS, CORTICAL SCREWSMerete Medical GmbH·Product code HWC·2013-04-05
K130469 — LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3DiaSorin, Inc.·Product code JLW·2013-04-05
K130521 — ISOLATOR LINEAR PENAtriCure, Inc.·Product code OCL·2013-04-05
K130588 — MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc.·Product code DQX·2013-04-05
K130698 — DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)Siemens Healthcare Diagnostics·Product code JIT·2013-04-05
K130744 — LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDERCovidien·Product code GEI·2013-04-05
K130782 — ACCUMESH DEPLOYMENT SYSTEMCovidien, LLC·Product code ORQ·2013-04-05
K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAYSiemens Healthcare Diagnostics, Inc.·Product code NHX·2013-04-04
K121951 — LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3DiaSorin, Inc.·Product code CEC·2013-04-04
K122194 — LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBEEveryway Medical Instruments Co.,Ltd·Product code KPI·2013-04-04
K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical Corporation·Product code LFR·2013-04-04
K123263 — HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUSEckert & Ziegler Bebig GmbH·Product code MUJ·2013-04-04
K123507 — KCI NPWT GAUZE DRESSINGKci USA, Inc.·Product code OMP·2013-04-04
K123732 — HYSTEROSCOPY PUMP HM6W.O.M. World of Medicine AG·Product code HIG·2013-04-04
K123808 — AGILITYElekta , Ltd.·Product code IYE·2013-04-04
K130422 — PHANTOM FIBER BIOFIBER SUTURETornier, Inc.·Product code NWJ·2013-04-04
K130765 — ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup·Product code JIX·2013-04-04
K123829 — PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACKPortable Therapeutix, LLC·Product code IRP·2013-04-03
K123942 — STRYKER IVAS BALLOON CATHETERStryker Corporation·Product code NDN·2013-04-03
K130023 — K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTORNp Medical, Inc.·Product code FPA·2013-04-03
K130194 — ACCULIF XL CAGECoalign Innovations, Inc.·Product code MAX·2013-04-03
K130285 — PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENSThe Lagado Corp.·Product code LRX·2013-04-03
K130423 — THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525Richard Wolf Medical Instruments Corp.·Product code FET·2013-04-03
K130659 — SPEQRT ULTRASOUND SYSTEMSignostics Pty, Ltd.·Product code IYN·2013-04-03
K121916 — INTUITIONTerarecon,Inc.·Product code LLZ·2013-04-02
K123541 — SYNGO.CT NEURO PERFUSIONSiemens Medical Systems, Inc.·Product code JAK·2013-04-02
K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOSBossong Hosiery Mills, Inc.·Product code DWL·2013-04-02
K123860 — INMODE SR IPL DEVICEInmode MD , Ltd.·Product code ONF·2013-04-02
K123943 — AMECATH DUAL LUMEN HEMODIALYSIS CATHETERAmeco Medical Industries·Product code MSD·2013-04-02
K124042 — TANDA MINI SKINCARE SYSTEMSyneron Beauty·Product code OLP·2013-04-02
K130361 — THERMOFINDER; THERMOCAREHubdic Co., Ltd.·Product code FLL·2013-04-02
K130453 — EXCELSIOREyekor, LLC·Product code NFJ·2013-04-02
K130470 — BD MAX CDIFF ASSAY, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc. (Bd Diagnostics)·Product code OZN·2013-04-02
K130576 — CELSITE IMPLANTABLE ACCESS PORT SYSTEMSB. Braun Interventional Systems, Inc.·Product code LJT·2013-04-02
K120056 — HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSERThe Binding Site Group , Ltd.·Product code DFH·2013-04-01
K120561 — NEUROBLATE SYSTEMMonteris Medical, Inc.·Product code GEX·2013-04-01
K123445 — NMI COAXIAL MICROINTRODUCER SETNavilyst Medical, Inc.·Product code DRE·2013-04-01
K123733 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEMMedtronic, Inc.·Product code OCL·2013-04-01
K123850 — IFUSE IMPLANT SYSTEMSI-BONE, Inc.·Product code OUR·2013-04-01
K123906 — VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEMMedtronic Sofamor Danek USA, Inc.·Product code KWP·2013-04-01
K123954 — INFINITY TOTAL ANKLE SYSTEMWrightmedicaltechnologyinc·Product code HSN·2013-04-01
K123972 — WALKAIDE SYSTEMInnovative Neurotronics, Inc.·Product code GZI·2013-04-01
K123997 — TRANS1LATERAL INTERBODY FUSION SYSTEMTrans1, Inc.·Product code MAX·2013-04-01
K130286 — STREAMLINE MIS SPINAL FIXATION SYSTEMPioneer Surgical Technology, Inc.·Product code NKB·2013-04-01
K130402 — SPIDER SYSTEM KOLIBRI CEMENT NEEDLESintea Plustek, LLC·Product code NDN·2013-04-01
K122221 — NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETERTaidoc Technology Corporation·Product code FLL·2013-03-29
K122501 — AEI DR. TERAUCHI ULTRASONIC TIPSAmerican Eagle Instruments, Inc.·Product code ELC·2013-03-29
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500Litecure, LLC·Product code PDZ·2013-03-29
K123407 — CELLULAZE LASERCynosure, Inc.·Product code OYW·2013-03-29
K123484 — SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENSSt. shine Optical Co., Ltd.·Product code LPL·2013-03-29
K123509 — SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEMHitachi Medical Systems America, Inc.·Product code JAK·2013-03-29
K123562 — FLOWER SMALL AND MEDIUM BONE IMPLANTSFlower Orthopedics Corporation·Product code HRS·2013-03-29
K123642 — MUSCLE STIMULATION SYSTEMNiveus Medical, Inc.·Product code IPF·2013-03-29
K123789 — SWIFT FX NANOResmed, Ltd.·Product code BZD·2013-03-29
K124008 — IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCAREIvoclar Vivadent, Agin·Product code NHA·2013-03-29
K130223 — RMGI FILLPulpdent Corporation·Product code EMA·2013-03-29
K130497 — D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATIONLinvatec Corporation D/B/A Conmed Linvatec·Product code HBC·2013-03-29
K130537 — BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKERBiopsy Sciences, LLC·Product code NEU·2013-03-29
K130653 — ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUEthicon Endo-Surgery, LLC·Product code GDW·2013-03-29
K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLC·Product code BXN·2013-03-28
K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEMTecres S.P.A.·Product code NDN·2013-03-28
K122272 — CARDIOMEMGetemed Medizin- Und Informationstechnik AG·Product code MWJ·2013-03-28
K122744 — PROSPERA OTC TENS ELECTRONIC PULSE MASSAGERProspera Corporation·Product code NUH·2013-03-28
K122770 — BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831Biomet Manufacturing Corp·Product code HRS·2013-03-28
K122850 — TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICESMeditech Advisors, LLC·Product code ODP·2013-03-28
K123100 — INTESS LUMBAR CAGEKalitec Direct, LLC·Product code MAX·2013-03-28
K123139 — ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIESAsi Medical, Inc.·Product code ELC·2013-03-28
K123178 — STRYKER VENOM ELECTRODES AND CANNULAEStryker Instruments, Instruments Div.·Product code GXI·2013-03-28
K123272 — 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUMNeocoil, LLC·Product code MOS·2013-03-28
K123338 — BARRICADE EMBOLIZATION COIL SYSTEMBlockade Medical·Product code HCG·2013-03-28
K123512 — BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMBiodenta Swiss AG·Product code DZE·2013-03-28
K123624 — OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEMMimosa Acoustics, Inc.·Product code EWO·2013-03-28
K123964 — AXSOS 3 TI LOCKING PLATE SYSTEMStryker Trauma AG·Product code HRS·2013-03-28
K123984 — QUANTIEN MEASUREMENT SYSTEMRadi Medical Systems AB·Product code DQK·2013-03-28
K130176 — FIREBIRD SPINAL FIXATION SYSTEMOrthofix·Product code NKB·2013-03-28
K130336 — 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540Eizo Nanao Corporation·Product code LLZ·2013-03-28
K130483 — BOEHRINGER GASTRIC SIZING TUBEBoehringer Laboratories, LLC·Product code KNT·2013-03-28
K130625 — 12MM AND 13MM TIBIAL NAILSAdvanced Orthopaedic Solutions, Inc.·Product code HSB·2013-03-28
K113823 — HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KITThe Binding Site Group , Ltd.·Product code CFN·2013-03-27
K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICWescor, Inc.·Product code JFS·2013-03-27
K122480 — INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTInternational Biophysics Corporation·Product code BYI·2013-03-27
K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTHemostasis, LLC·Product code LYA·2013-03-27
K123762 — DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFFMedtronic, Inc.·Product code DWF·2013-03-27
K123859 — TBDLensar, Inc.·Product code OOE·2013-03-27
K123870 — XPEED ANYRIDGE INTERNAL IMPLANT SYSTEMMegagen Implant Co., Ltd.·Product code DZE·2013-03-27
K124029 — MICROLINE FLEXIBLE LIGATING SHEARSMicroline Surgical, Inc.·Product code GEI·2013-03-27
K122362 — SMART-WELL INCUBATORMesa Laboratories, Inc.·Product code FRC·2013-03-26

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