510(k) Clearances — Page 63
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243296 — Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251145 — Arthrex PushLock Suture Anchors | Arthrex, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250063 — ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251830 — Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243252 — ZBPro Diagnostic | Zbeats, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251169 — Vivid Pioneer | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250283 — RAP Femoral Venous Cannulae | LivaNova USA, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250072 — CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250247 — panaSIa SI Fusion System | Wenzel Spine, Inc. Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250133 — HARBOR Occlusion Device | Nuvascular, Inc. Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243500 — ARCHITECT iGentamicin | Abbott Laboratories Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243731 — HEXIM Implant; Samwon General Abutments | P&A USA Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Boston Scientific Corporation Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250505 — EZ-FIDUCIALS | Phasor Health, LLC Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250108 — OptiVu Shoulder | Mr Surgical Solutions, LLC Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251520 — Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. Wed Jul 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250695 — Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251766 — TumorSight Viz | SimBioSys, Inc. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251741 — PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241525 — ExcelsiusXR | Globus Medical, Inc. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250065 — DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. Tue Jul 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243884 — TAVIPILOT | Caranx Medical Mon Jul 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. Mon Jul 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250496 — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co., Ltd. Mon Jul 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. Mon Jul 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251863 — CustomSurg OrthoPlanner | Customsurg AG Mon Jul 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250398 — Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251528 — syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | The Magstim Company Limited Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243826 — SMR Reverse HP Shoulder System | Lima Corporate S.P.A. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243220 — Onera STS 2 (ONERA STS 2) | Onera B.V. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251390 — MTA vpt | Voco GmbH Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251599 — Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251080 — IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243678 — TalisMann Neuromodulation System | Bioventus, LLC Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |