510(k) Clearances — Page 150
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233748 — CIARTIC Move (VB10) | Siemens Medical Solutions USA, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240466 — STARband 3D | Orthomerica Products, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233799 — Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) | Shenzhen Yuezhongxing Technology Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240454 — RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233342 — CINA-ASPECTS | Avicenna.Ai Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232234 — Nouvo Safety Set | Poly Medicure Limited Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234104 — PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233747 — Concha Sol Hearing Aids (CL-1001) | Concha Labs Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240539 — Vital Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233307 — Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240430 — Otoport Pro | Otodynamics, Ltd. Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233881 — ivWatch® Model 400 | Ivwatch, LLC Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231529 — CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | Stryker Leibinger GmbH & Co KG Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231850 — QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232567 — Myriad SPECTRA Light Source | Nico Corporation Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232980 — SpermAlign Sperm Separation Device | Cytoswim, Ltd. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232301 — Define RF Microneedling System | Aesthetic Management Partners Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233958 — hekaDrill | Zethon, Ltd. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | Nxstage Medical, Inc. Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234008 — CERAMENT G | Bonesupport AB Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233952 — DEKA ACE Pump System | Deka Research and Development Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | Chongqing Rob Linka Science and Technology Co., Ltd. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233968 — CINA-iPE | Avicenna.Ai Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234002 — ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234055 — DEKA Loop | Deka Research and Development Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233949 — ACCORD Cable System | Smith & Nephew, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233136 — Hygeia Express Powered Breast Pump | Hygeia II Medical Group, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232022 — CAS-One IR | Cascination AG Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233466 — Edison System | HistoSonics, Inc. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233946 — IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233930 — MRCP+ version 2 (MRCP+ v2) | Perspectum Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233592 — BioPoly Radial Head Implant | BioPoly, LLC Wed Mar 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240416 — Tranquil-C Interbody System | Nexus Spine, LLC Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Collagen Matrix, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240132 — EmoLED (v. 2-USA) | Emoled, Srl Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | Baxter Healthcare Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232564 — Align Studio | Laon Medi, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240497 — Smartxide Tetra Pro | El.En S.P.A. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233381 — DRX-Evolution Plus System | Carestream Health, Inc. Tue Mar 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | Satelec - Acteon Group Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | Luminex Molecular Diagnostics, Inc. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233724 — 28mm/38D MDM X3 Insert for MDM Liner | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |