510(k) Clearances — Page 137
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233674 — Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232505 — Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | Zhejiang Curaway Medical Technology Co., Ltd. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240838 — Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233025 — Revolution External Plating System | New Standard Device Dba Metalogix Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234003 — The Circadia C200 System | Circadia Technologies, Ltd. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232934 — Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233126 — aetherSlide | Aetherai Co., Ltd. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240687 — SofWave System | Sofwave Medical, Ltd. Thu May 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241235 — Arthrex TightRope II | Arthrex, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232741 — SmartAdjust(TM) technology | Insulet Corporation Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233481 — AltiVate Reverse® Glenoid | Encore Medical L.P. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233655 — Lingo Glucose System | Abbott Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233389 — EK Digital Abutments | Hiossen, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233166 — NET Recovery Corp/NET Device | Net Recovery Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240049 — LINK(TM) External Fixator | Metric Medical Devices, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240159 — InnoVoyce VYLO | Innovoyce Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232672 — EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241207 — SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) | Devoro Medical, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240784 — Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240305 — ANNE Limb | Sibel Health, Inc. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240629 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Xingyu Medical Tech Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240304 — Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223629 — SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241177 — React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233076 — Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240874 — Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) | Theralaser Medtech (China) Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233344 — Regenalase Laser System | Ipg Medical Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240410 — EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240749 — PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231426 — 8plant Implant System | Hoowon Edi Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240592 — Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240864 — PacePro Wire | Opsens, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232632 — Racz Neurostat RF Generator | Epimed International Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233111 — ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC | Foshan United Medical Technologies, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241178 — DEKA ACE Pump System | Deka Research and Development Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233285 — KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231939 — Renasys Edge | Smith & Nephew Medical, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233089 — NeoSpan® Compression Implant System | In2bones USA, LLC Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233386 — Monik - Disposable Endoscopic Trocar | M/s. Meril Endo Surgery Private Limited. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240810 — Anti Grinding Guard | Xiamen Yizhou Imp. & Exp. Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240769 — LVivo IQS | Dia Imaging Analysis, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232788 — INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234154 — uPMR 790 | Shanghai United Imaging Healthcare Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232639 — Apollo TMS Therapy System | Mag & More GmbH Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240827 — SET-5002 | Shimadzu Corporation Medical Systems Division Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |