510(k) Clearances — Page 120
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241723 — Electric wheelchair (W3902) | Zhejiang Richall Medical Technology Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241356 — Fine Osteotomy | Bodycad Laboratories, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241155 — Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233998 — TRAQinform IQ | Aiq Global, Inc. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | Intradin (Shanghai) Machinery Co., Ltd. Thu Sep 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231502 — Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221275 — Qraycam PRO | AIOBIO Co., Ltd. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240158 — Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Fujifilm Corporation Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233977 — Velacur | Sonic Incytes Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231095 — Tamper Evident Cap | International Medical Industries, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242305 — BE Plus PRO, Neurotravel LIGHT | Eb Neuro S.P.A. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241071 — NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240646 — DreamClear | Somnomed Technologies Inc., Doing Business AS Remware Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242306 — SignalNED System (Model RE) | Forest Devices, Inc. Wed Sep 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242251 — Litho 60; Litho 100; Litho 150 | Quanta System Spa Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw System | Eminent Spine Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240487 — EVOS Patella Plates | Smith & Nephew Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242319 — Indigo® Aspiration System Aspiration Catheter 6X | Penumbra, Inc. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241295 — SOMATOM On.site | Siemens Medical Solutions USA, Inc. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233805 — K5 | Osstem Implant Co., Ltd. Chair Business Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241611 — ShapeIT (SI014135) | Imds Operations B.V. Tue Sep 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241592 — Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. Sat Aug 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241393 — ODI-Tech | Odi Medical AS Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233872 — Daylight | Big Health, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241386 — Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241148 — Salto Talaris Ankle PSI System | 3D Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241602 — Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 | Canon Medical Systems Corporation Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242275 — syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240180 — Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242300 — MI View&GO | Siemens Medical Solutions USA, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234027 — embecta Insulin Delivery System | Embecta Medical I, LLC Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242249 — Conformity Stem Extension Line | United Orthopedic Corporation Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241518 — Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | The Magstim Company Limited Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241847 — Imbio PHA (4.0.0) | Imbio, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241823 — ToxiSeal Vial Adaptor | Epic Medical Pte. , Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233932 — Alinity i Toxo IgM | Abbott Laboratories Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241585 — uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Remington Medical, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241051 — Vave Wireless Ultrasound System | Vave Health, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241662 — Ultrasound Transducer Cover | Vitrolife Sweden AB Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241326 — Cadence Ankle PSI System | 3D Systems, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240003 — Velmeni for Dentists (V4D) | Velmeni, Inc. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232441 — Unipro (K-UNIPRO-US) | Tenscare, Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241957 — Talee, Talee PostOp | Invent Medical USA, LLC Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231969 — BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | Dongguanshi Yiyingmei Technology Co., Ltd. Fri Aug 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |