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

HAE 2025-06-06

Geister K-Rex rongeurs

Applicant Geister Medizin Technik GmbH

K-Number K242759

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FLE 2025-06-06

Steam Sterilizer (2545D)

Applicant Ningbo Ican Machines Co., Ltd.

K-Number K243994

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KNS 2025-06-06

SpydrBlade Flex Instrument (PRD-RG1-001)

Applicant Creo Medical, Ltd.

K-Number K242774

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OUR 2025-06-06

Omnia Medical PsiF DNA™ System

Applicant Omnia Medical, LLC

K-Number K242431

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OWY 2025-06-06

TYBR Collagen Gel

Applicant Tybr Health

K-Number K250109

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FGB 2025-06-06

KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

Applicant Karl Storz SE & CO. KG

K-Number K243550

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LPH 2025-06-06

ONVOY™ Acetabular System

Applicant Globus Medical, Inc.

K-Number K243456

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FDT 2025-06-05

Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

Applicant Olympus Medical Systems Corp.

K-Number K250701

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LNH 2025-06-05

Sonic DL

Applicant Ge Medical Systems, LLC

K-Number K243667

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LLZ 2025-06-05

UroNav 4

Applicant Philips DS North America, LLC

K-Number K250800

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OLO 2025-06-05

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

Applicant Medtronic Navigation, Inc.

K-Number K242464

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OAP 2025-06-05

Red Light Hair Growth Cap (LP-RJVGRW-BLK)

Applicant Shenzhen Idea Light Limited

K-Number K250467

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