510(k) Clearances — Page 191
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231174 — BPBIO750 | Inbody Co., Ltd. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231942 — Mineral Collagen Composite Bioactive Extra Moldable | Collagen Matrix, Inc. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230748 — Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223553 — Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231126 — Eblator Device | E Surgical, LLC Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223821 — Self-Cath Closed System | Coloplast Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231344 — ActivSight Intraoperative Imaging System | Activ Surgical, Inc. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223114 — Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223689 — Disposable Needle Guides and Grids | Advance Medical Designs, Inc. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231593 — Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232030 — Ingenia Elition R5.7.1 SP4 MR Systems | Philips Medical Systems Nederland B.V. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221114 — Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231286 — Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231620 — Nuubo Smart | Smart Solutions Technologies SL Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231959 — EXPD 4357; EXPD 4357P | DRTECH Corporation Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231278 — Knotless Suture Anchor | Riverpoint Medical, LLC Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | Ga Health Company Limited Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231963 — REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230162 — uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231591 — V-Print c&b temp | Voco GmbH Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230956 — BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System | Bd Integrated Diagnostic Solutions / Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231613 — Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. | Zhuzhou Goldenhot Medical Technology Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230004 — Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231321 — Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232088 — Altris IMS | Altris, Inc. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230630 — ZENEX Implant System_Narrow | Izenimplant Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231698 — AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230858 — QUATERA 700 | Carl Zeiss Meditec, AG Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223567 — CNS-2101 Central Monitor | Nihon Kohden Corporation Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221767 — Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223097 — RenaNav Ureteroscope System | CenterPoint Systems, LLC Mon Jul 31 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222862 — SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Lotuxs Medtech (Suzhou) Co., Ltd. Sun Jul 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222735 — HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231618 — 3 Layer Surgical Mask (134252531) | Original Mattress Factory, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | Pentax of America, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231931 — Adena-Zina Spinal System | Shanghai Sanyou Medical Co, Ltd. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231480 — Bright MTA Sealer Plus | Genoss Co., Ltd. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222587 — PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222794 — FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231589 — Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222902 — Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230898 — FLUOBEAM® LX Red | Fluoptics Sas Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230801 — Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223781 — Quantisal II Oral Fluid Collection Device | Immunalysis Corporation Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231073 — SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231951 — SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230813 — BlueStar and BlueStar Rx | Welldoc, Inc. Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |