510(k) Clearances — Page 60
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243407 — Forcyte Autograft Harvest Kit | Forcyte Medical, LLC Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251364 — Sleepiz One+ (2.5) | Sleepiz AG Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251061 — NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251220 — NUVENTUS NV.C Prosthetic Components | Infinitum Eta, Ltd. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243489 — Alinity m EBV (09N43-095) | Abbott Molecular, Inc. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241183 — ISO Abutment | Seum Medi Co., Ltd. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Changsha Anxiang Medical Technology Co., Ltd. Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250859 — TransForm McCarthy Mitral Annuloplasty Ring (TF) | Genesee Biomedical, Inc. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250244 — Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251665 — Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250989 — Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252215 — InbellaMAX System | Inbella Medical , Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243244 — Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251322 — Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250334 — Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251620 — A.L.P.S. Proximal Humerus Plating System | Zimmer Biomet Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250232 — Vathin® Video Bronchoscope System | Hunan Vathin Medical Instrument Co., Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250970 — Marie | Leo Cancer Care Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243403 — BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252033 — Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | CMT Health PTE., Ltd. Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250284 — TSK SELECT Needle | Tsk Laboratory, Japan Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100) | AtriCure, Inc. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251618 — MOTO Partial Knee System Extension | Medacta International S.A. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251984 — Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251297 — MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252010 — SPY Laparoscope | Stryker Endoscopy Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250322 — Respond OC Conserving Regulator (130-0800) | Responsive Respiratory Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251955 — Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243681 — Neuro Insight V1.0 | Olea Medical S.A.S. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251265 — Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250716 — IMAGE ONE | Infomed Software, S.L. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Edwards Lifesciences Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251280 — DESS® Dental Implants | Terrats Medical SL Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Innovasis, Inc. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251748 — MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251213 — Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250280 — SD TL Implant System | Arum Dentistry Co., Ltd. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250590 — MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |