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

LLL 2025-10-22

Alegria Flash CTD Screen

Applicant Zeus Scientific

K-Number K250666

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OAP 2025-10-22

Hair Growth Laser Cap

Applicant Cosmo Far East Technology Limited

K-Number K252325

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HGX 2025-10-22

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

Applicant Ningbo Youhe Electrical Appliance Technology Co., Ltd.

K-Number K251977

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GAT 2025-10-22

Pre-Sutured Tendon

Applicant Rti Surgical, Inc.

K-Number K253145

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OUR 2025-10-22

SIros-X System

Applicant Genesys Spine

K-Number K252322

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FMZ 2025-10-22

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

Applicant Datex-Ohmeda, Inc.

K-Number K251663

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QEW 2025-10-22

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

Applicant Intervene

K-Number K251185

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QJP 2025-10-22

Carrier XL Delivery Catheter

Applicant Balt USA, LLC

K-Number K252569

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LRK 2025-10-22

Mandibular Advancement Device L07

Applicant Dcstar, Inc.

K-Number K251628

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QIH 2025-10-22

ANDI 2.0

Applicant Imeka Solutions, Inc.

K-Number K252298

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OBJ 2025-10-22

XC11 ICE System, USA

Applicant Yorlabs, Inc.

K-Number K250955

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NKB 2025-10-21

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K252346

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