510(k) Clearances

174,759 clearances total

K242559 — Digital TempSprintray, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242657 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mLThermo Fisher Scientific Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241390 — NeuroMatchLVIS Corporation Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243050 — TriMed Posterior Malleolus Fixation SystemTriMed, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231655 — 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243118 — Arm Blood Pressure Monitor (model: BPM-A7VL)Shenzhen Imdk Medical Technology Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242049 — SureCath SetColoplast Corp. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240818 — R2P Radifocus Glidewire AdvantageTerumo Corporation Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240897 — CellinewVIOL Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231859 — PrimmaArtDentscare Ltda Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242631 — REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242961 — Intraluminal Applicator SetVarian Medical Systems Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242318 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232588 — Aluna 2Knox Medical Diagnostics Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241851 — Versus™ Catheter (VS110-8B)Liquet Medical, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241588 — Electric Wheelchair (KR8803)Zhejiang Kairui Medical Device Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241831 — Transpara (2.1.0)Screenpoint Medical B.V. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241692 — MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242245 — Customized AbutmentArum Dentistry Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232982 — EMS Sculpt MachineShandong Huamei Technology Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243345 — Aptima BV Assay; Aptima CV/TV AssayHologic, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242253 — JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)Eemagine Medical Imaging Solutions GmbH Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242538 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243162 — World LinerSignature Orthopaedics Pty, Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242971 — AccurSound Electronic Stethoscope (AS101)Heroic Faith International , Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243334 — Nooro Body & Foot Stimulator (SM9141, SM9142)Xf Agencija Limited Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233567 — OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241169 — Entarik NI Feeding Tube SystemGravitas Medical, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241953 — SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241529 — Powered Wheelchair (NXN20-209)Zhejiang Nysin Medical Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242259 — Cala kIQCala Health, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242002 — FemVue MINI Saline-Air DeviceFemasys, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242094 — Dreem 3SBeacon Biosignals, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242913 — Jasmate® ToothpasteJasberry Healthcare Private Limited Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242884 — Additively Manufactured Denture ResinAidite (Qinhuangdao) Technology Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242927 — Suction Irrigation Tubing SetAdvamedix, GmbH Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240632 — Neuvotion NeuStim NN-01Neuvotion, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K221326 — Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242203 — BriefCase-QuantificationAidoc Medical , Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242968 — Giftlife® Single-Step Medium PlusGimbo Medical Technology Shenzhen Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242722 — Manual Wheelchair (MASY23)Sichuan Ast Medical Equipment Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242596 — Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241319 — SKR 3000Konica Minolta, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242998 — GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241495 — Jazz ClassicJazz Imaging Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242874 — Gating Reflector BlockVarian Medical Systems, Inc. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232520 — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBHShenzhen Smallsignal Technology Co., Ltd. Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
← Previous Page 91 of 3496 Next →