FDA 510(k) clearances — page 225

176,542 clearances on record, most recent first.

Clearances — page 225

22,401–22,500 of 176,542

K190024 — Smart-CTurner Imaging Systems, Inc.·Product code OXO·2019-09-27
K190059 — CEREC GuidesDentsply Sirona·Product code NDP·2019-09-27
K190076 — Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid·Product code OYX·2019-09-27
K191074 — Sorrento Bone Graft SubstituteXenco Medical, LLC·Product code MQV·2019-09-27
K191444 — Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous ReservoirMedtronic, Inc.·Product code DTZ·2019-09-27
K191521 — Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation·Product code LHN·2019-09-27
K191747 — FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation·Product code FDT·2019-09-27
K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)Biomerieux S.A.·Product code JWY·2019-09-27
K192112 — FlexBand PlusInternational Life Sciences·Product code FTL·2019-09-27
K192129 — ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact LensClearlab SG Pte, Ltd.·Product code LPL·2019-09-27
K192352 — MiniMAXMedacta International S.A.·Product code LZO·2019-09-27
K192368 — CATSmartFresenius Kabi AG·Product code CAC·2019-09-27
K192421 — EpiFaith SyringeFlat Medical Co., Ltd.·Product code FMF·2019-09-27
K182009 — Dia-ProsealDiaDent Group International·Product code KIF·2019-09-26
K190029 — Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed TrocarChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd·Product code GCJ·2019-09-26
K190199 — SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation·Product code MQL·2019-09-26
K190454 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended CuffHartalega NGC Sdn. Bhd.·Product code LZA·2019-09-26
K190466 — PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl CitrateShen Wei USA, Inc.·Product code LZA·2019-09-26
K191336 — PRECICE SystemNuvasive Specialized Orthopedics, Inc.·Product code HSB·2019-09-26
K191530 — StoneCheckerImaging Biometrics, LLC·Product code LLZ·2019-09-26
K191537 — eCarbon IBDsBack 2 Basics Direct, LLC·Product code ODP·2019-09-26
K191545 — Exogenesis Hernia MeshExogenesis Corporation·Product code FTL·2019-09-26
K191748 — Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine·Product code OUR·2019-09-26
K192195 — Sterile DilatorGalt Medical Corp.·Product code DRE·2019-09-26
K192364 — GXR-Series Diagnostic X-Ray SystemDRGEM Corporation·Product code KPR·2019-09-26
K192371 — BioZorb SP MarkerFocal Therapeutics·Product code NEU·2019-09-26
K192391 — Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH·Product code OBO·2019-09-26
K192435 — NuVasive NuvaLineNu Vasive, Incorporated·Product code LLZ·2019-09-26
K183190 — NuStatBeeken Biomedical, LLC·Product code POD·2019-09-25
K183675 — 3D Visualization SystemScivita Medical Technology Co., Ltd.·Product code GCJ·2019-09-25
K183687 — LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.·Product code MWI·2019-09-25
K190022 — SafeBreath Filter MouthpieceMD Diagnostics Limited·Product code CAH·2019-09-25
K190323 — Aloe Glide LubricantDesert Harvest, Inc.·Product code NUC·2019-09-25
K190536 — Mediracer NCSMediracer OY·Product code JXE·2019-09-25
K190875 — EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International)·Product code HQC·2019-09-25
K191742 — ARIES MRSA AssayLuminex Corporation·Product code NQX·2019-09-25
K191765 — OMNI TiN Coated Apex Knee SystemOmni Life Science, Inc.·Product code JWH·2019-09-25
K191791 — TranS1 Interbody Fusion SystemTrans1·Product code MAX·2019-09-25
K192011 — PhoeniXSedecal., Sa.·Product code IZL·2019-09-25
K192102 — Thermoplastic MasksAktina Medical Corporation·Product code IYE·2019-09-25
K183391 — Novidia Universal BondNobio , Ltd.·Product code KLE·2019-09-24
K190574 — Patient Assistant Model PA97000Medtronic, Inc.·Product code DSI·2019-09-24
K191006 — EasiSlushBridge TO Life, Ltd.·Product code KDN·2019-09-24
K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemMedos International SARL·Product code PGM·2019-09-24
K191718 — Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG·Product code NXO·2019-09-24
K191998 — Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.·Product code OLO·2019-09-24
K192010 — SmoothSkin BARE+Cyden Limited·Product code OHT·2019-09-24
K192354 — Innovasis Gibralt Spine SystemInnovasis, Inc.·Product code NKG·2019-09-24
K190100 — USTAR II SystemUnited Orthopedic Corporation·Product code KRO·2019-09-23
K190483 — SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies·Product code MAX·2019-09-23
K192322 — T-Stat 2.0 Microvascular Tissue OximeterSpectros Corporation·Product code MUD·2019-09-23
K182671 — Medi-Direct TENS PenJkh USA, LLC·Product code NUH·2019-09-21
K180523 — INTAI Surgery Navigation SystemIntai Technology Corporation·Product code OLO·2019-09-20
K181428 — Clyra Wound Irrigation SolutionClyra Medical Technologies, Inc.·Product code FRO·2019-09-20
K190001 — Supercath 5Togo Medikit Co., Ltd.·Product code FOZ·2019-09-20
K190856 — SeeFactorCT3Epica International, Inc.·Product code OAS·2019-09-20
K191324 — CivaDermCivatech Oncology, Inc.·Product code KXK·2019-09-20
K191679 — Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation·Product code QFG·2019-09-20
K191927 — Hinged Laminoplasty SystemLife Spine, Inc.·Product code NQW·2019-09-20
K192259 — Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V.·Product code PSY·2019-09-20
K192276 — Merge CardioMerge Healthcare Incorporated·Product code LLZ·2019-09-20
K192296 — Medtronic 6F Taiga Guiding CatheterMedtronic Vascular·Product code DQY·2019-09-20
K192301 — BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.·Product code NFW·2019-09-20
K192332 — ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever SheathInari Medical·Product code QEW·2019-09-20
K192402 — syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.·Product code JAK·2019-09-20
K182631 — SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)Eurogreen International, Inc.·Product code INI·2019-09-19
K190526 — High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.·Product code PML·2019-09-19
K191112 — GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC·Product code KGI·2019-09-19
K192030 — RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.·Product code IYN·2019-09-19
K192252 — ProPerformance Recovery SystemMenlo Brands, LLC·Product code IRP·2019-09-19
K192326 — HardyDisk AST Lefamulin 20µg (LMU20)Hardy Diagnostics·Product code JTN·2019-09-19
K192344 — Sapphire NC Plus Coronary Dilatation CatheterOrbusneich Medical Trading, Inc.·Product code LOX·2019-09-19
K182292 — VORTRAN APM-PlusVortran Medical Technology 1, Inc.·Product code CAP·2019-09-18
K183103 — EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd.·Product code NGX·2019-09-18
K183436 — OraCureTbm Corporation·Product code OLR·2019-09-18
K190563 — 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF CageSolco Biomedical Co., Ltd.·Product code MAX·2019-09-18
K190858 — Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal LubricantUnited Consortium·Product code NUC·2019-09-18
K191113 — geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited·Product code IPF·2019-09-18
K191187 — Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.·Product code EYB·2019-09-18
K191232 — AccuCath Ace Intravascular CatheterC.R. Bard, Inc.·Product code FOZ·2019-09-18
K191357 — Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.·Product code FAJ·2019-09-18
K191391 — HEDRON Lumbar SpacersGlobus Medical, Inc.·Product code MAX·2019-09-18
K191457 — BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH·Product code PFO·2019-09-18
K191552 — GM501 Mineral OilHamilton Thorne, Inc.·Product code MQL·2019-09-18
K191663 — Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation·Product code IYN·2019-09-18
K192065 — Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.·Product code MUJ·2019-09-18
K192254 — InnoSight Diagnostic Ultrasound SystemQisda Corporation·Product code IYN·2019-09-18
K181416 — Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.·Product code LRK·2019-09-17
K183708 — Poly ClearMedtek Skincare, LLC·Product code OLP·2019-09-17
K190049 — Sim&SizeSim&Cure·Product code PZO·2019-09-17
K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)Amd Medicom, Inc.·Product code OXZ·2019-09-17
K191243 — HEDRON Cervical SpacersGlobus Medical, Inc.·Product code ODP·2019-09-17
K191253 — Reusable NIBP CuffShenzhen Changke Connect Electronics Co., Ltd.·Product code DXQ·2019-09-17
K191297 — iNSitu Bipolar Hip SystemTheken Companies, LLC·Product code KWY·2019-09-17
K191842 — Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa·Product code GEX·2019-09-17
K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensUnicon Optical Co., Ltd.·Product code LPL·2019-09-17
K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return CordMaquet Cardiovascular, LLC·Product code GEI·2019-09-17
K192037 — Advisor VL Circular Mapping Catheter, Sensor EnabledABBOTT MEDICAL·Product code DRF·2019-09-17
K192059 — Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc.·Product code ODC·2019-09-17
K190507 — Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.·Product code DXN·2019-09-16

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