Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JWY 2025-02-10

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

Applicant Thermo Fisher Scientific

K-Number K242905

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NGX 2025-02-10

OTC TENS & EMS Unit

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K243511

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CJY 2025-02-10

Calcium2

Applicant Abbott Ireland

K-Number K244042

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QIH 2025-02-10

Ultrasound Workspace (UWS 6.0)

Applicant Philips Ultrasound, LLC

K-Number K241659

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NFO 2025-02-10

Myolight Microcurrent Handpiece

Applicant Raja Trading Company, Inc.

K-Number K243063

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KPI 2025-02-10

BTL-398

Applicant BTL Industries, Inc.

K-Number K241516

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QWH 2025-02-07

Elecsys sFlt-1 and Elecsys PlGF

Applicant Roche Diagnostics

K-Number K241453

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LZO 2025-02-07

ceramys femoral head system

Applicant Encore Medical L.P.

K-Number K241483

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OVE 2025-02-07

Genesys Spine AIS-C II Cervical Interbody Fusion System

Applicant Genesys Spine

K-Number K242483

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EBF 2025-02-07

Any-Com Bulk

Applicant Mediclus Co., Ltd.

K-Number K242713

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DXN 2025-02-07

Electronic Blood Pressure Monitor

Applicant Hetaida Technology Co., Ltd.

K-Number K243661

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NFT 2025-02-07

AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup

Applicant Assure Tech., LLC

K-Number K243996

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