Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

KWQ 2025-07-11

Resolve Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K-Number K251436

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GCJ 2025-07-11

Disposable Trocars

Applicant Sinolinks Medical Innovation, Inc.

K-Number K250820

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BSZ 2025-07-11

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

Applicant Codonics.Incorporated

K-Number K251352

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OZE 2025-07-11

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Applicant Centers for Disease Control and Prevention

K-Number K243274

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LYA 2025-07-11

TurbAlign

Applicant Spirair, Inc.

K-Number K243655

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ITX 2025-07-11

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Applicant Olympus Medical Systems Corporation

K-Number K250762

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JFB 2025-07-11

Ceragem Automatic Thermal Massager (CGM MB-2401)

Applicant Ceragem Co., Ltd.

K-Number K250266

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NLH 2025-07-11

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K250772

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KNW 2025-07-11

Disposable Biopsy Needle

Applicant Carbon (Shenzhen) Medical Device Co., Ltd.

K-Number K243296

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IYO 2025-07-11

B-Scan

Applicant Accutome, Inc. Doing Business AS Keeler USA

K-Number K243227

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HIS 2025-07-11

Natural rubber latex male condom

Applicant Shaoguan Regenex Pharmaceuticals Co., Ltd.

K-Number K250034

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GEX 2025-07-11

AviClear Laser System

Applicant Cutera, Inc.

K-Number K251149

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