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

JAD 2025-01-10

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

Applicant Carl Zeiss Meditec, AG

K-Number K241174

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HXA 2025-01-10

Universal Tendon Spacer

Applicant Askorn Medical

K-Number K243477

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KNW 2025-01-10

Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)

Applicant Triopsy Medical, Inc.

K-Number K242228

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HWC 2025-01-10

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

Applicant Arthrex, Inc.

K-Number K243195

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OHS 2025-01-10

Ulike Reglow Light Therapy Device (UM10)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K243492

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OLO 2025-01-10

NuVasive Pulse System

Applicant Globus Medical, Inc.

K-Number K243814

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PRE 2025-01-10

TriVerity

Applicant Inflammatix, Inc.

K-Number K241676

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DXN 2025-01-10

Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)

Applicant Shenzhen Ruiankang Technology Co., Ltd.

K-Number K242528

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PCH 2025-01-10

BioCode Gastrointestinal Pathogen Panel (GPP)

Applicant Applied BioCode, Inc.

K-Number K242877

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QOF 2025-01-10

Xpert Xpress CoV-2/Flu/RSV plus

Applicant Cepheid

K-Number K242071

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OLI 2025-01-10

Erchonia Zerona® VZ8

Applicant Erchonia Corporation

K-Number K243811

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KNT 2025-01-10

ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

Applicant Tools For Surgery, LLC

K-Number K242901

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