FDA 510(k) clearances — page 254

176,542 clearances on record, most recent first.

Clearances — page 254

25,301–25,400 of 176,542

K182539 — 2MP Color LCD Monitor CL-R211Jvckenwood Corporation·Product code PGY·2018-10-03
K171696 — NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.·Product code MRN·2018-10-02
K173642 — KLOCKNER SURGICAL BOXSOADCO, S.L.·Product code KCT·2018-10-02
K181081 — Infrared Ear ThermometerJoytech Healthcare Co. , Ltd.·Product code FLL·2018-10-02
K181867 — Deka Smartxide2 TrioEl.En Electronic Engineering Spa·Product code GEX·2018-10-02
K181885 — Voyant SystemViseon, Inc.·Product code HRX·2018-10-02
K182051 — FUJIFILM Duodenoscope ModelFujifilm Corporation·Product code FDT·2018-10-02
K173716 — MPS2 Myocardial Protection System ConsoleQuest Medical, Inc.·Product code DTR·2018-10-01
K181445 — AMSure Hydrophilic Intermittent CatheterAmsino International, Inc.·Product code EZD·2018-10-01
K181622 — StrataMR guider toolMedtronic Neurosurgery·Product code JXG·2018-10-01
DEN170080 — Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation·Product code QDC·2018-09-28
K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.·Product code KSB·2018-09-28
K173872 — FibriCheckQompium NV·Product code DXH·2018-09-28
K180041 — BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.·Product code PCH·2018-09-28
K180068 — ORISE GelBoston Scientific·Product code PLL·2018-09-28
K180216 — Seidmon Antegrade AQ Stent SetCook Incorporated·Product code FAD·2018-09-28
K180241 — Orthocaps TwinalignerOrtho Caps GmbH·Product code NXC·2018-09-28
K180964 — Endoscope Sterilization TrayIntuitive Surgical, Inc.·Product code KCT·2018-09-28
K180973 — Libertas Hip Replacement SystemMaxx Orthopedics, Inc.·Product code JDI·2018-09-28
K180998 — BioHorizons CAD/CAM BarsBioHorizons Implant Systems, Inc.·Product code NHA·2018-09-28
K181088 — TSP Crosser Transseptal Access SystemTransseptal Solutions , Ltd.·Product code DYB·2018-09-28
K181124 — Acessa ProVu SystemAcessa Health, Inc.·Product code HFG·2018-09-28
K181277 — E-CUBE 12Alpinion Medical Systems Co., Ltd.·Product code IYN·2018-09-28
K181476 — Prime&Bond active Universal AdhesiveDentsply Sirona·Product code KLE·2018-09-28
K181652 — Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable SutureETHICON, Inc.·Product code GAM·2018-09-28
K181746 — MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.·Product code MAI·2018-09-28
K181771 — RightEye Vision SystemRighteye, LLC·Product code GWN·2018-09-28
K181794 — Truliant Porous Femoral ComponentsExactech, Inc.·Product code MBH·2018-09-28
K182039 — Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.·Product code PHX·2018-09-28
K182376 — HarmonyTopcon Medical Systems, Inc.·Product code NFJ·2018-09-28
K182415 — Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation·Product code OWB·2018-09-28
K173833 — CRP VarioSENTINEL CH. SpA·Product code NQD·2018-09-27
K181021 — EmboCube Embolization GelatinBiosphere Medical, S.A.·Product code KRD·2018-09-27
K181075 — PureSet TrayNobel Biocare AB·Product code KCT·2018-09-27
K181397 — DualXInnovasive, Inc.·Product code MAX·2018-09-27
K181608 — Disposable Standard ClampStandard Bariatrics·Product code GCJ·2018-09-27
K181742 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)Stryker GmbH·Product code KWS·2018-09-27
K181975 — Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30Oxoid Limited (Part of Thermo Fisher Scientific)·Product code JTN·2018-09-27
K182370 — Acculoc Total Knee SystemRootloc Co., Ltd.·Product code JWH·2018-09-27
K182377 — CarboClear® Pedicle Screw SystemCarboFix Orthopedics , Ltd.·Product code NKB·2018-09-27
K182402 — CoLink View Plating SystemIn2bones USA, LLC·Product code HRS·2018-09-27
K180340 — Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation·Product code CGA·2018-09-26
K180803 — BeautiBond UniversalShofu Dental Corporation·Product code KLE·2018-09-26
K181066 — Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs ClaimsEco Medi Glove Sdn. Bhd.·Product code LZA·2018-09-26
K181563 — The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnologyAccess Scientific, LLC·Product code DQY·2018-09-26
K181591 — Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC·Product code MAX·2018-09-26
K181707 — Everyway Wireless TENS & EMS UnitEveryway Medical Instruments Co.,Ltd·Product code NUH·2018-09-26
K181991 — NxStage Connected Health SystemNxstage Medical, Inc.·Product code FKP·2018-09-26
K182315 — Magic Torque DLVR GuidewireBoston Scientific Corporation·Product code DQX·2018-09-26
K182325 — InMode RF SystemInmode MD , Ltd.·Product code GEI·2018-09-26
K182357 — HardyDisk AST Eravacycline 20µg (ERV20)Hardy Diagnostics·Product code JTN·2018-09-26
K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)Skyla Corporation H.S.P.B·Product code LCP·2018-09-25
K181424 — PeDIAPedia, LLC·Product code BTC·2018-09-25
K181692 — 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)Health Beacons, Inc.·Product code NEU·2018-09-25
K181773 — Synapse 3D Optional ToolsFujifilm Corporation·Product code LLZ·2018-09-25
K181795 — AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd.·Product code IOR·2018-09-25
K181904 — 5 FR Dual Lumen Piper PICCPiper Access, LLC·Product code LJS·2018-09-25
K181980 — OsseoScrew SystemAlphatec Spine, Inc.·Product code NKB·2018-09-25
K182290 — IBM iConnect AccessMerge Healthcare Incorporated·Product code LLZ·2018-09-25
K182335 — CPX 4 Breast Tissue Expander with Smooth SurfaceMentor Worldwide, LLC·Product code LCJ·2018-09-25
K180714 — Probe Covers for ThermometersK-Jump Health Co., Ltd.·Product code FLL·2018-09-24
K180916 — iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc.·Product code LLZ·2018-09-24
K181366 — REDAPT Porous Acetabular ShellSmith & Nephew, Inc.·Product code LPH·2018-09-24
K181611 — Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp·Product code PHX·2018-09-24
K182317 — AMADEO M-DR mini, AMADEO M-AX miniOehm Und Rehbein GmbH·Product code IZL·2018-09-24
DEN070001 — NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and Prevention·Product code PBK·2018-09-21
K171947 — SOLOASSIST IIAktormed GmbH·Product code NAY·2018-09-21
K172418 — OpenSightNovarad Corporation·Product code LLZ·2018-09-21
K173960 — DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.·Product code LZO·2018-09-21
K180029 — Malecot Nephrostomy Catheter/Stent SetCook Incorporated·Product code FAD·2018-09-21
K180144 — Agile Esophageal Stent SystemBoston Scientific Corporation·Product code ESW·2018-09-21
K180338 — CellulizeWard Photonics, LLC·Product code OLI·2018-09-21
K180489 — TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant·Product code ONB·2018-09-21
K181006 — BB-613 Watch OximeterBio-Beat Technologies , Ltd.·Product code DQA·2018-09-21
K181034 — Pocket Colposcope SystemHadleigh Health Technologies, LLC·Product code HEX·2018-09-21
K181200 — AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.·Product code JCT·2018-09-21
K181616 — PSM 3-Way Silicone Foley CatheterPathway, LLC·Product code EZL·2018-09-21
K181665 — BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GNBecton, Dickinson and Company·Product code LON·2018-09-21
K181702 — Tranquil-L Interbody SystemNexus Spine, LLC·Product code MAX·2018-09-21
K181769 — Arthrex FiberTak Suture AnchorArthrex, Inc.·Product code MBI·2018-09-21
K181789 — VeriSuiteMedcom GmbH·Product code LHN·2018-09-21
K181926 — InVivo Web ViewerAnatomage, Inc.·Product code LLZ·2018-09-21
K182043 — Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)Hebei Titans Hongsen Medical Technology Co., Ltd.·Product code LYZ·2018-09-21
K182258 — AquaShield System CO2; AquaShield System CO2 - PENTAX; AquaShield System CO2 - FujifilmUnited States Endoscopy Group, Inc.·Product code FEQ·2018-09-21
K182310 — Volpara Imaging SoftwareVolpara Health Technologies Limited·Product code LLZ·2018-09-21
K182345 — Spineology Navigation InstrumentsSpineology, Inc.·Product code OLO·2018-09-21
K173898 — MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)·Product code LZO·2018-09-20
K180366 — EndoTool SubQAl Pacheco and Associates·Product code NDC·2018-09-20
K181199 — Katalyst Mark 1 Muscle Stimulation System Model 2Katalyst, Inc.·Product code NGX·2018-09-20
K181205 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention·Product code PBK·2018-09-20
K181305 — OralTox Oral fluid Drug TestPremier Biotech, Inc.·Product code DJC·2018-09-20
K181420 — Aequalis Flex Revive Shoulder SystemTornier, Inc.·Product code KWS·2018-09-20
K181726 — Medline Patient Cables and Lead WiresMedline Industries, Inc.·Product code DSA·2018-09-20
K181783 — LOGIQ P9; LOGIQ P7GE Healthcare·Product code IYN·2018-09-20
K181995 — Chiral Surgical Pedicle Screw SystemChiral Surgical·Product code NKB·2018-09-20
K182340 — NICO MyriadNico Corporation·Product code GEI·2018-09-20
K173141 — CSM Submerged3-L Implant SystemCsm Implant·Product code DZE·2018-09-19
K173982 — FORTIFY Corpectomy SpacersGlobus Medical, Inc.·Product code MQP·2018-09-19
K180781 — Bard Vertus Foley CatheterC.R. Bard, Inc.·Product code EZL·2018-09-19
K180893 — IHM Technology BandageProtege Biomedical·Product code QSY·2018-09-19

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