510(k) Clearances — Page 190

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 190 of 3,525)
ClearancesDetails
K233185 — MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel SystemC2Dx, Inc. Oct 24, 2023
K232356 — Laser Cap, Model: Hat-01Hubei Yjt Technology Co.,Ltd Oct 24, 2023
K230919 — Acumen IQ finger cuffEdwards Lifesciences, LLC Oct 24, 2023
K232223 — PlaDuo SystemShenB Co., Ltd. Oct 24, 2023
K232211 — REUNION Sacroiliac Joint Fusion SystemAstura Medical Oct 24, 2023
K232086 — spineEOSEos Imaging Oct 24, 2023
K232051 — VISULAS greenCarl Zeiss Meditec Oct 24, 2023
K232586 — Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp. Oct 24, 2023
K232638 — FilteredFlo Warming BlanketsIob Medical, Inc. Oct 24, 2023
K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus PenicillinbioMerieux, Inc. Oct 23, 2023
K230893 — Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A Oct 23, 2023
K232205 — Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed SetVesco Medical, LLC Oct 23, 2023
K230281 — PICOCLAMPKono Seisakusho Co., Ltd. Oct 23, 2023
K232143 — Applanation Tonometer HT-5000Huvitz Co., Ltd. Oct 23, 2023
K232305 — AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A. Oct 23, 2023
K231732 — CleanSeal Advanced Bipolar Vessel Sealer MarylandConmed Corporation Oct 23, 2023
K233258 — Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC Oct 23, 2023
K231764 — Ultrasound System 1300Bk Medical Aps Oct 23, 2023
K232561 — Ripley Spinal Screw System by SAGICOSagico VA USA, LLC Oct 23, 2023
K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. Oct 23, 2023
K232091 — JO Coconut Hybrid Cooling Personal LubricantCC Wellness, LLC Oct 22, 2023
K231539 — pRESET LITE Thrombectomy DevicePhenox Limited Oct 21, 2023
K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC Oct 20, 2023
K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)Ansell Healthcare Oct 20, 2023
K232922 — Pure-Vu EVS SystemMotus GI Medical Technologies , Ltd. Oct 20, 2023
K232236 — EchoQuanta System Spa Oct 20, 2023
K230998 — Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited Oct 20, 2023
K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USA Oct 20, 2023
K223557 — SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH Oct 20, 2023
K230983 — Unicare (K-UNICARE-USA)Tenscare, Ltd. Oct 20, 2023
K223909 — R2GATE Lite TMMegagen Implant Co., Ltd. Oct 20, 2023
K231578 — Lucitone Digital Print Denture SystemDentsply Sirona Oct 20, 2023
K233065 — V-PRO maX 2 Low Temperature Sterilization SystemSteris Oct 20, 2023
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 Oct 20, 2023
K230209 — Sonix HealthOntact Health Co., Ltd. Oct 20, 2023
K231388 — NextDent BaseVertex-Dental B.V. Oct 20, 2023
K232550 — Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd. Oct 20, 2023
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 Oct 20, 2023
K232371 — Actinia® hip stemsImplantcast GmbH Oct 19, 2023
K231664 — IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc. Oct 19, 2023
K230478 — Acro Composites Interbody SystemAcro Composites, LLC Oct 19, 2023
K231381 — Xpert Xpress MVP; GeneXpert Xpress SystemCepheid Oct 19, 2023
K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc. Oct 19, 2023
K232905 — Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP Oct 19, 2023
K230178 — EasyOne Sky SpirometerNdd Medizintechnik AG Oct 19, 2023
K231749 — Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd. Oct 19, 2023
K230476 — Oran Park MaskResmed Pty Ltd (Registration Number: 3004604967) Oct 19, 2023
K230459 — C.C. Life 2121 Equipment S.R.L. Oct 19, 2023
K232484 — KeyLift™ Expandable Interlaminar Stabilization SystemAmplio Spine, LLC Oct 19, 2023
K232910 — CombiDiagnost R90Philips Medical Systems Dmc GmbH Oct 19, 2023
← Previous Page 190 of 3525 Next →