510(k) Clearances — Page 159
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231416 — Air Next (NVD-02) | Nuvoair AB Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230592 — LuxCreo Dental Night Guard Resin | LuxCreo, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231762 — uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | William Cook Europe Aps Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233031 — M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233226 — FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233445 — Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | Integra Lifesciences Production Corporation Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234030 — Clear Guide SCENERGY | Clear Guide Medical Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233730 — Footprint Mini PK, 3.5mm Suture Anchor | Smith & Nephew Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231871 — Radify Triage | Envisionit Deepai, Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233710 — Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | Co-Innovation Biotech Co., Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231135 — Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. Wed Jan 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233512 — Rapid (6.0) | Ischemaview, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223266 — Hilzo Esophageal Stents | Thoracent, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232355 — Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | SteriLance Medical (Suzhou), Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233970 — Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233293 — Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® | Neurosigma, Inc. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231144 — Washtrays | Dentsply Sirona Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232062 — Uni-port | Dalim Medical Corp. Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231138 — Aniti-Snore Mouthguard+ | Oscimed SA Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223234 — Delta4 Insight | Scandidos AB Tue Jan 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232350 — Stryker Facial iD System | Stryker Craniomaxillofacial Sat Jan 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233216 — CLEWICU System | Clew Medical , Ltd. Sat Jan 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233355 — Cypris eXact Suturing System | Cypris Medical Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233144 — ClearPoint Bone Screw Fiducials | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233677 — Biograph VK10 | Siemens Medical Solutions USA, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233125 — Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222783 — MD Mattress Suture Placement Device | Lsi Solutions, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232970 — Hem-o-lok® Ligating Clips | Teleflex Medical Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231315 — Velox Power Chair | Velox Manufacturing, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | Owens & Minor (O&M) Halyard, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231371 — BEE Cervical Cage | NGMedical GmbH Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231558 — SMB Luer lock disposable syringe | Smb Corporation of India Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232032 — PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232990 — ATOMIC Nitinol Fixation System | Rmr Ortho, LLC Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230008 — DermaSensor | Dermasensor, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230015 — Osteoboost Belt | Bone Health Technologies, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232170 — Ti Link Abutment | Izenimplant Co., Ltd. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231970 — PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | Pentax of America, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233155 — ClearPointer Optical Navigation Wand | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231684 — Quick - Radius Disposable Set | GM Dos Reis Industria e Comercio Ltda. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233141 — SmartFrame OR | ClearPoint Neuro, Inc. Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233694 — Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation Fri Jan 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |