510(k) Clearances

174,759 clearances total

K230998 — Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230983 — Unicare (K-UNICARE-USA)Tenscare, Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232922 — Pure-Vu EVS SystemMotus GI Medical Technologies , Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223909 — R2GATE Lite TMMegagen Implant Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231578 — Lucitone Digital Print Denture SystemDentsply Sirona Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K233065 — V-PRO maX 2 Low Temperature Sterilization SystemSteris Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232042 — NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021);Mediconcepts Technology (Shenzhen) Company Limited Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230209 — Sonix HealthOntact Health Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231388 — NextDent BaseVertex-Dental B.V. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232550 — Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd. Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232951 — BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)Steris Fri Oct 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230178 — EasyOne Sky SpirometerNdd Medizintechnik AG Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232905 — Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230478 — Acro Composites Interbody SystemAcro Composites, LLC Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231749 — Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231381 — Xpert Xpress MVP; GeneXpert Xpress SystemCepheid Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232371 — Actinia® hip stemsImplantcast GmbH Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231664 — IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230459 — C.C. Life 2121 Equipment S.R.L. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232484 — KeyLift™ Expandable Interlaminar Stabilization SystemFlospine Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232910 — CombiDiagnost R90Philips Medical Systems Dmc GmbH Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231976 — StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc. Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230476 — Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967) Thu Oct 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231781 — OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230199 — Byte Aligner SystemDentsply Sirona, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231395 — INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232123 — MectaLIF Anterior Lag ExtensionMedacta International S.A. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231225 — EConsole1DRTECH Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232897 — Arthrex Small External Fixation SystemArthrex, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231907 — Medline Safety Insulin and TB SyringesMedline Industries, LP Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232924 — T-Line® Hernia MeshDeep Blue Medical Advances, Inc. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231824 — SmartBolus CalculatorInsulet Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231826 — Omnipod 5 ACE PumpInsulet Corporation Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science and Technology Co., Ltd. Wed Oct 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232903 — Legend X PlatformPollogen, Ltd. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232878 — TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc) Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223911 — Lumen 155-SFIntricon Corporation Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231899 — HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232151 — Dynamic TiBaseTalladium España, SL Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232089 — SOZO ProImpediMed Limited Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc. Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)Hunan Endoso Life Technology Co., Ltd. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K232020 — Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230249 — IkshanaImmersivetouch Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230570 — Willow Generation 3 Breast PumpWillow Innovations, Inc. Mon Oct 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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