510(k) Clearances — Page 91
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243511 — OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241659 — Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241516 — BTL-398 | BTL Industries, Inc. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240958 — Locking Plates and Screws Systems | Hebei Ruihe Medical Devices Co., Ltd. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243453 — Philips Lumea IPL | Philips Consumer Lifestyle B.V. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244042 — Calcium2 | Abbott Ireland Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243516 — Remi Custom Night Guard | Grindguard, Inc. Mon Feb 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242404 — BDC Dental Unit | Bdc Dental Corporation , Ltd. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241483 — ceramys femoral head system | Encore Medical L.P. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242713 — Any-Com Bulk | Mediclus Co., Ltd. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242368 — Symani Surgical System | Medical Microinstruments, Inc. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243780 — HELIOS 785 Pico (1754V2) | Laseroptek Co., Ltd. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243661 — Electronic Blood Pressure Monitor | Hetaida Technology Co., Ltd. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241453 — Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242957 — Identify (4.0) | Varian Medical Systems, Inc. Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242324 — DUTAU-NOVATECH® | Novatech SA Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243784 — Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244034 — Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Ever Global (Vietnam) Enterprise Corporation Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243465 — Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) | Guangzhou Chuang Zao Mei Technology Co., Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250055 — BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242192 — Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242580 — Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies, Inc. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241599 — Signature Osteosynthesis Plate System | Signature Orthopaedic Pty , Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243794 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241702 — CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250061 — Celerity Incubator | STERIS Corporation Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242111 — VIVACE | Unimom.Co Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243817 — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243243 — Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243488 — VMAT PRO | Termosalud Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. Thu Feb 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243580 — GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242352 — Accurate Mini Non-invasive blood pressure monitor (AMB-001) | Accurate Meditech, Inc. Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242896 — Caliber Intramedullary Fixation System | Nvision Biomedical Technologies Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243555 — LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242983 — CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243790 — GRYPHON X Anchor; HEALIX TRANSTEND Anchor | Depuy Mitek Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241488 — TrainFES Advance | Trainfes Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241593 — BoneMetrics (US) | Gleamer Sas Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243138 — Geon (S2) Nasal Aspirator | Geon Corporation Tue Feb 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243333 — rTOP | Roclub GmbH Tue Feb 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |