FDA 510(k) clearances — page 305

176,542 clearances on record, most recent first.

Clearances — page 305

30,401–30,500 of 176,542

K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter SetCook Incorporated·Product code BWC·2017-02-17
K160799 — GenNarinoSaliwell , Ltd.·Product code LTF·2017-02-17
K161411 — Care Cycle Connect ApplicationRespironics, Inc.·Product code MOD·2017-02-17
K161953 — ReDe MaskTereopneuma·Product code PRK·2017-02-17
K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia·Product code LCP·2017-02-17
K162824 — Z-Span Plate SystemZavation, LLC·Product code KWQ·2017-02-17
K162875 — Sentry IVC filterNovate Medical , Ltd.·Product code DTK·2017-02-17
K163037 — Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc.·Product code HRX·2017-02-17
K163260 — SeptiCyte LABImmunexpress, Inc.·Product code PRE·2017-02-17
K163651 — ExpressBraid Graft ManipulationBiomet Manufacturing Corp·Product code GAT·2017-02-17
DEN140033 — CompanionLgch, Inc.·Product code POS·2017-02-16
K153561 — AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring SystemAndon Health Co, Ltd.·Product code NBW·2017-02-16
K161437 — VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)bioMerieux, Inc.·Product code LON·2017-02-16
K161521 — TAP Blood Collection DeviceSeventh Sense Biosystems, Inc.·Product code PRJ·2017-02-16
K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression ScrewSynthes USA Products, LLC·Product code HWC·2017-02-16
K161764 — SLIT LAMP, Model: YF-100Chongqing Yeasn Science-Technology Co., Ltd.·Product code HJO·2017-02-16
K161996 — 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc.·Product code MQV·2017-02-16
K162007 — STERRAD NX SterilizerAdvanced Sterilization Products·Product code MLR·2017-02-16
K162365 — T-CuffTerumobct, Inc.·Product code KCY·2017-02-16
K162402 — 4CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.·Product code ODP·2017-02-16
K162481 — RF1400 Active Compression WrapRecovery Force, LLC·Product code JOW·2017-02-16
K162570 — Miromatrix Biological Mesh TWMiromatrix Medical, Inc.·Product code FTM·2017-02-16
K162760 — Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.·Product code OVE·2017-02-16
K162833 — VitriGuardOrigio A/S·Product code MQK·2017-02-16
K162849 — Huvex Interspinous Fixation SystemDio Medical Co., Ltd.·Product code PEK·2017-02-16
K162965 — SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.·Product code FTM·2017-02-16
K163165 — AM-100BTL Industries, Inc.·Product code NGX·2017-02-16
K163374 — ALLY Facet ScrewsProvidence Medical Technology, Inc.·Product code MRW·2017-02-16
K163416 — Fiagon Navigation PointerTube Straight and PointerTube KeatFiagon GmbH·Product code PGW·2017-02-16
K163549 — ClotTriever Thrombectomy SystemInari Medical, Inc.·Product code QEW·2017-02-16
K163602 — Kepler I Cervical Plate SystemOrbbo Surgical, LLC·Product code KWQ·2017-02-16
K170103 — Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.·Product code GCJ·2017-02-16
K170170 — Valleylab FT10 Electrosurgical PlatformCovidien, LLC·Product code GEI·2017-02-16
K160876 — PC ECGEdan Instruments, Inc.·Product code DPS·2017-02-15
K161811 — Medela Low Dose Enteral SyringeMedela, Inc.·Product code PNR·2017-02-15
K162099 — IBS Implant System IIInnobiosurg Co., Ltd.·Product code DZE·2017-02-15
K170160 — Abbott ARCHITECT Free T3Abbott Laboratories·Product code JIT·2017-02-15
DEN160048 — FilmArray NGDS Warrior PanelBiofire Defense, LLC·Product code PRD·2017-02-14
K162590 — Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd.·Product code ILY·2017-02-14
K162608 — ClariFix DeviceArrinex, Inc.·Product code GEH·2017-02-14
K162668 — Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.·Product code DXN·2017-02-14
K162830 — SIS SoftwareSurgical Information Sciences, Inc.·Product code LLZ·2017-02-14
K162987 — FA100 SCCD (Sequential Continuous Contraction Device)Flowaid Medical Technologies, Corp·Product code IPF·2017-02-14
K163085 — Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC·Product code OZN·2017-02-14
K163285 — syngo Application SoftwareSiemens Medical Solution USA, Inc.·Product code LLZ·2017-02-14
K163460 — Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.·Product code MXD·2017-02-14
K163548 — ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC·Product code GEI·2017-02-14
K163619 — SIGNA PET/MRGe Medical Systems, LLC·Product code OUO·2017-02-14
K170163 — Erisma® LP Spinal Fixation SystemClariance, Sas·Product code NKB·2017-02-14
K160610 — Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator SetKobold, LLC·Product code JAQ·2017-02-13
K160918 — JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora·Product code EBI·2017-02-13
K161510 — VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)bioMerieux, Inc.·Product code LON·2017-02-13
K162456 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid·Product code OCC·2017-02-13
K162508 — KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc.·Product code FRO·2017-02-13
K162860 — MCS Bone GraftBioventus, LLC·Product code MQV·2017-02-13
K163146 — POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy DrugsHebei Hongsen Plastics Technology Co, Ltd.·Product code LZC·2017-02-13
K163380 — Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC·Product code PNO·2017-02-13
K163487 — Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.·Product code JDW·2017-02-13
K170193 — Advance 14LP Low Profile PTA Balloon Dilatation CatheterCook Incorporated·Product code LIT·2017-02-13
K161213 — XSmart iQDentsply Sirona·Product code EBW·2017-02-10
K161226 — Revision Femoral StemLima Corporate S.P.A.·Product code LZO·2017-02-10
K161415 — SteriTite Containers System & MediTray ProductsCase Medical, Inc.·Product code FRG·2017-02-10
K161606 — Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHTerumo Europe N.V.·Product code FMF·2017-02-10
K161629 — CRYLREXSm Eng Co., Ltd.·Product code GAM·2017-02-10
K162089 — Blood Pressure MonitorBeijing Choice Electronic Technology Co., Ltd.·Product code DXN·2017-02-10
K162321 — EasyClip XpressRestore Surgical, LLC Dba Instratek·Product code JDR·2017-02-10
K162697 — Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.·Product code KWS·2017-02-10
K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)Medtronic, Inc.·Product code DTR·2017-02-10
K163217 — GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.·Product code OXF·2017-02-10
K163395 — Astroglide Diamond Silicone Gel Personal LubricantBiofilm, Inc.·Product code NUC·2017-02-10
K163596 — LOGIQ P9 and LOGIQ P7GE Healthcare·Product code IYN·2017-02-10
K161334 — RASL Repair KitRadicle Orthopaedics, Inc.·Product code HWC·2017-02-09
K161413 — Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc.·Product code KNT·2017-02-09
K161491 — Scopis Hybrid Navigation System EMScopis GmbH·Product code PGW·2017-02-09
K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialBecton Dickinson·Product code MDB·2017-02-09
K161861 — APTUS® Coronoid 2.0Medartis AG·Product code HRS·2017-02-09
K162158 — Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.·Product code NPM·2017-02-09
K162331 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid·Product code OCC·2017-02-09
K162611 — PeriFLEXSpiration, Inc.·Product code EOQ·2017-02-09
K162710 — Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and ReloadTgs Medical Co., Ltd.·Product code GDW·2017-02-09
K162918 — Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.·Product code MAX·2017-02-09
K163046 — DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongDePuy Synthes·Product code HRS·2017-02-09
K163184 — cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.·Product code LSL·2017-02-09
K163289 — syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI·Product code JAK·2017-02-09
K163341 — syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.·Product code JAK·2017-02-09
K163478 — AcuNav Volume ICE CatheterSiemens Medical Solutions USA, Inc.·Product code OBJ·2017-02-09
K163508 — PIVOVelano Vascular·Product code JKA·2017-02-09
K163566 — Hubble I SystemOrbbo Surgical, LLC·Product code NKB·2017-02-09
K170086 — Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.·Product code MUJ·2017-02-09
K170091 — UA-Cellular CompleteStreck·Product code JJW·2017-02-09
K170113 — pixium 4343RCEPhilips Medical Systems Dmc GmbH·Product code MQB·2017-02-09
K160444 — FB-U HemodialyzerNipro Medical Corporation·Product code KDI·2017-02-08
K161432 — MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC·Product code OMP·2017-02-08
K161468 — Transformair Indoor Air PurifierTransformair, LLC·Product code FRA·2017-02-08
K161577 — Arm-Type Fully Automatic Digital Blood Pressure MonitorSejoy Electronics & Instruments Co., Ltd.·Product code DXN·2017-02-08
K162039 — OptosAdvance 4.0 SoftwareOptos Plc.·Product code NFJ·2017-02-08
K162479 — Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd.·Product code NUH·2017-02-08
K162491 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)Hartalega Sdn Bhd·Product code LZA·2017-02-08
K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics·Product code MRG·2017-02-08
K162852 — Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical GloveLucenxia Prescience AG·Product code KGO·2017-02-08

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