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

NKB 2025-08-28

JAZZ Spinal System

Applicant Implanet

K-Number K252437

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JWY 2025-08-28

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

Applicant Thermo Fisher Scientific

K-Number K252014

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CBK 2025-08-28

SV600, SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K243767

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CCK 2025-08-28

Medical Gas Analyzer (AG200)

Applicant Prior Care Science Technology, Ltd.

K-Number K250148

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NAY 2025-08-28

da Vinci SP Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K252350

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PGY 2025-08-28

RadiForce GX570; RadiForce GX570-AR

Applicant Eizo Corporation

K-Number K252030

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JAK 2025-08-28

CT:VQ

Applicant 4Dmedical Limited

K-Number K251484

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NUH 2025-08-28

OTC 4-Channel Rechargeable TENS Unit

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K251429

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KWQ 2025-08-28

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

Applicant Alphatec Spine, Inc.

K-Number K251965

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PHX 2025-08-28

JARVIS Glenoid Reverse Shoulder Prosthesis

Applicant FH Industrie

K-Number K252411

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NXC 2025-08-27

Additively Manufactured Aligner Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K251415

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OCT 2025-08-27

KnoxFog Anti-fogging Device

Applicant Uv One Hygienics, Inc.

K-Number K251068

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