510(k) Clearances — Page 197
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230337 — EarliPoint | Earlitec Diagnostics, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231691 — Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230866 — HotDog Warming Mattress + Return Electrode | Augustine Temperature Management, LLC Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231101 — Flume Catheter | Flume Catheter Company, Ltd. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223596 — SQ.line KERRISON | Aesculap, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN200052 — KidneyIntelX.dkd | Renalytix Ai, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231553 — OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222933 — MYAH | Visia Imaging S.R.L. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230176 — Upper Arm Blood Pressure Monitor | Shenzhen Yolanda Technology Co., Ltd. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223047 — NeuroSwift Pro | Neurobit Technologies Co., Ltd. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230595 — OsteoCentric ACL Fixation System | OsteoCentric Technologies Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231647 — XENOVIEW 3.0T Chest Coil | Polarean, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System | Boston Scientific Corporation Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221436 — F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. Thu Jun 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231232 — Curiteva Laminoplasty System | Curiteva, Inc. Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230859 — Aneroid Sphygmomanometer | Wenzhou Kangshun Medical Devices Co.,Ltd Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220198 — Medi Lift PLUS | Ya-Man, Ltd. Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K210924 — e-Celsius Medical System | Bodycap Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | Microlife Intellectual Property GmbH Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223722 — MIO Blood Glucose Monitoring System | Mio Labs, Inc. Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230706 — EMBOLD Soft Detachable Coil System | Boston Scientific Corporation Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Medline Industries, Inc. Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222492 — Hope&Her Vaginal Dilators | Lujena, Inc. Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231636 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. | L&K BIOMED Co., Ltd. Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231219 — NobelZygoma PureSet Tray | Nobel Biocare Services AG Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213046 — AceConnex Pre-Sutured Fascia | Allosource Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230876 — RI.KNEE Adjustable Tibia Cut Guide | Enztec Limited Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | Owen Mumford, Ltd. Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230861 — VADER® Pedicle System Navigated Instruments | Icotec AG Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231215 — IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S | Zhongshan Qizhe Technology Co., Ltd. Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230492 — Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc. Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223143 — SAGICO Spinal System | Sagico VA USA, LLC Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230867 — Bone Bolt System | University of Utah, Department of Orthopaedics Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221488 — Z7 Zirconia Implant System | Z7, LLC Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | ArthroCare Corporation Mon Jun 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222142 — BR SLA Type Implant System | Biotem Co., Ltd. Sat Jun 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222323 — Black Diamond | Elevate Oral Care, LLC Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223638 — Neodent Implant System - Helix Short Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230518 — HydraDose Vaginal Suppositories | MD Labs, LLC Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223187 — HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231505 — GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223048 — Medisystem Pacs | Medilab Manutencao E Sitemas Ltda Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230160 — VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E | Vinno Technology (Suzhou) Co.,Ltd Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231117 — neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230369 — EUROPA Navigated Instruments | MiRus, LLC Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223019 — sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC Fri Jun 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |