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

QSZ 2025-06-20

NovoSorb BTM

Applicant Polynovo Biomaterials Pty, Ltd.

K-Number K251567

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QJP 2025-06-20

FUBUKI XF-R Neurovascular Long Sheath

Applicant Asahi Intecc Co., Ltd.

K-Number K251560

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DWJ 2025-06-20

Celsi Warmer

Applicant Hadleigh Health Technologies

K-Number K242964

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PGW 2025-06-20

Navient Image Guided Navigation System (ENT) (955-NC-NC)

Applicant Claronav

K-Number K243053

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LFX 2025-06-20

Alinity i Rubella IgG

Applicant Abbott Laboratories

K-Number K243168

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OHS 2025-06-20

LED Facial Mask

Applicant Shenzhen Sunsred Technology Co.,Ltd

K-Number K243978

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CAF 2025-06-20

AdheResp Smart Breath-actuated Mesh Nebulizer

Applicant Hcmed Innovations Co., Ltd.

K-Number K250583

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JWY 2025-06-20

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

Applicant Thermo Fisher Scientific

K-Number K242843

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GEI 2025-06-19

Electrosurgical Pads

Applicant Baisheng Medical Co., Ltd.

K-Number K251235

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POS 2025-06-19

EpiMonitor

Applicant Empatica S.r.l.

K-Number K250515

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OAT 2025-06-19

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

Applicant Leone S.P.A.

K-Number K242944

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OLO 2025-06-18

SPINEART Navigation Instrument System

Applicant Spineart SA

K-Number K242933

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