510(k) Clearances in 2023 — Page 15

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 15 of 67)
510(k) clearancesDetails
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
K231976 — StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc. Oct 19, 2023
K232897 — Arthrex Small External Fixation SystemArthrex, Inc. Oct 18, 2023
K230199 — Byte Aligner SystemDentsply Sirona, Inc. Oct 18, 2023
K231225 — EConsole1DRTECH Corporation Oct 18, 2023
K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V. Oct 18, 2023
K231395 — INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. Oct 18, 2023
K231781 — OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. Oct 18, 2023
K232123 — MectaLIF Anterior Lag ExtensionMedacta International S.A. Oct 18, 2023
K231826 — Omnipod 5 ACE PumpInsulet Corporation Oct 18, 2023
K231907 — Medline Safety Insulin and TB SyringesMedline Industries, LP Oct 18, 2023
K232924 — T-Line® Hernia MeshDeep Blue Medical Advances, Inc. Oct 18, 2023
K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd. Oct 18, 2023
K231824 — SmartBolus CalculatorInsulet Corporation Oct 18, 2023
K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)Qingdao Kingon Medical Science And Technology Co., Ltd. Oct 18, 2023
K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. Oct 17, 2023
K223911 — Lumen 155-SFIntricon Corporation Oct 17, 2023
K232903 — Legend X PlatformPollogen, Ltd. Oct 17, 2023
K232878 — TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc) Oct 17, 2023
K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH Oct 17, 2023
K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc. Oct 17, 2023
K231899 — HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. Oct 17, 2023
K232151 — Dynamic TiBaseTalladium España, SL Oct 17, 2023
K232089 — SOZO ProImpediMed Limited Oct 17, 2023
K231725 — Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)Hunan Endoso Life Technology Co., Ltd. Oct 16, 2023
K232118 — ANDORATE® Valve KitGa Health Company Limited Oct 16, 2023
K232020 — Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd. Oct 16, 2023
K230570 — Willow Generation 3 Breast PumpWillow Innovations, Inc. Oct 16, 2023
K230249 — IkshanaImmersivetouch Oct 16, 2023
K230104 — Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr Oct 16, 2023
K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. Oct 14, 2023
K231672 — S1Medpark Co., Ltd. Oct 13, 2023
K230741 — Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd. Oct 13, 2023
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