510(k) Clearances — Page 83
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242022 — Access Toxo IgG | Beckman Coulter, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242919 — V5med Lung AI | V5med, Inc. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244046 — Edwards eSheath Optima introducer set | Edwards Lifesciences Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243038 — Salix Central | Artrya Limited Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250555 — MallyaD injection pen adapter (MallyaD) | Biocorp Production Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250092 — HC Biologics Osteopoint Spinal Fixation System | HC Biologics, LLC Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241962 — Crossloop | Asahi Intecc Co., Ltd. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243426 — Nurochek-Pro System | Headsafe Mfg Pty, Ltd. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242201 — HyperSuture White/Green Extension Line | Threadstone, LLC Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243768 — iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241862 — Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics , Ltd. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241785 — StarFormer (M008-3T) | Fotona D.O.O. Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242745 — AI-Rad Companion Organs RT | Siemens Healthcare GmbH Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250134 — Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250194 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | Shenzhen Ulike Smart Electronics Co., Ltd. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243995 — Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250542 — AC3 Range Intra-Aortic Balloon Pump | Arrow International, LLC Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240189 — NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto, Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243831 — Rayvolve LN | AZmed Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242669 — SnapshotGLO (KB100) | Kent Imaging, Inc. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243891 — EarliPoint System | Earlitec Diagnostics Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244003 — Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250668 — Aventus Thrombectomy System (IM-2100) | Inquis Medical Tue Mar 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250225 — Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. Tue Mar 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250125 — LMNT O2 | Xplr , Ltd. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243642 — UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250603 — AxTiHA® Stand-Alone ALIF System | Innovasis Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250013 — VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / Dba Ventiv Scientific Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241921 — Alinity m BKV | Abbott Molecular, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250182 — Innovasis Navigation Instruments | Innovasis, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242356 — TIDAL Fusion Cage System | Restor3D, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243991 — Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243865 — AERO MIS Facet Fusion System | Aurora Spine Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243525 — SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie Mon Mar 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | Stryker Neurovascular Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242564 — Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243958 — Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243185 — REMI Remote EEG Monitoring System | Epitel Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243630 — Medical Laser System Incanto / Evoline Platinum /Evoline | Solar LS Cjsc Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Fri Mar 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |