510(k) Clearances — Page 141
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240685 — Salvo® Spine System | Spine Wave, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233800 — Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC Mon May 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233524 — Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | Hollister Incorporated Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232454 — Viral Transport Media (VTM) | Alb Luz Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240800 — Access Intrinsic Factor Ab | Beckman Coulter, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233157 — VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz, LLC Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240126 — ProAM ALIF System | Pro Surgical, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232735 — EMA 3D | Ema Sleep Incorporated Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232491 — CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234088 — Emily's Care Nourish Test System (Model 1) | Lactation Lab, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233349 — Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233687 — ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240185 — Cypris eXact Suture Placement Device | Cypris Medical Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240625 — CORUS Navigation Access System | Providence Medical Technology, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240940 — Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232941 — Megaloop Button System | Suzhou Endophix Co., Ltd. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240919 — Silk Voice (SMI-04) | Sofregen Medical Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232895 — B-Ultrasound Diagnostic System | Contec Medical Systems Co.,Ltd Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232648 — RODEO Telescopic Nail | Orthofix Srl Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232733 — Mbrace Cable | Medacta International S.A. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240297 — Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232776 — Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer | Outset Medical, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232416 — AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234021 — Masimo Stork | Masimo Corporation Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240012 — Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240037 — Revi System | Bluewind Medical , Ltd. Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | Contec Medical Systems Co.,Ltd Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233752 — Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | CenterPoint Systems, LLC Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233689 — Hope&Her Vaginal Dilators | Lujena, Inc. Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240636 — HemoScreen Hematology Analyzer | Pixcell Medical Technologies Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232445 — CSF-4 (CSF-4) | Cardiacsense Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232902 — EVA15 insufflator | Palliare , Ltd. Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233857 — Neodent Implant System Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232464 — VereSee Optical Veres Needle System | Freyja Healthcare, LLC Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240829 — AuST Steerable Sheath | CenterPoint Systems, LLC Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233513 — Remex Spine Surgery Navigation System II | Remex Medical Corp. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232858 — ORskin Blue | Megabay S.A. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240882 — BruxZir® Esthetic | Prismatik Dentalcraft, Inc. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231722 — SmarTooth | Smartooth Co., Ltd. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240925 — DuraGraft Vascular Conduit Solution | Marizyme Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240900 — HOTWIRE RF Guidewire | Atraverse Medical Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233284 — Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232370 — Percutaneous Nephroscope System | Karl Storz SE & CO. KG Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240986 — Cold Compression | Jkh Health Co., Ltd. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240279 — VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233203 — Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |