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

HIH 2025-06-03

RZ Resectoscope System

Applicant Rz Medizintechnik GmbH

K-Number K243382

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OUR 2025-06-03

Patriot SI Implant System

Applicant Spinal Simplicity, LLC

K-Number K250001

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DQY 2025-06-02

GORE® Tri-Lobe Balloon Catheter

Applicant W. L. Gore & Associates, Inc.

K-Number K250410

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MBI 2025-06-02

PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

Applicant Science & Bio Materials (S.B.M.) Sas

K-Number K250844

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MAX 2025-06-02

Tera Lumbar Interbody Fusion System (Various PNs)

Applicant Acuity Surgical Devices, LLC

K-Number K251335

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FED 2025-06-02

CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K250452

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JPA 2025-06-02

Automated Blood Coagulation Analyzer CN-Series (CN-6000)

Applicant Sysmex America, Inc.

K-Number K250965

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PDU 2025-05-31

LimFlow ARC

Applicant LimFlow, Inc.

K-Number K251376

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QAS 2025-05-30

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K251406

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QME 2025-05-30

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

Applicant Mindset Medical, Inc.

K-Number K250078

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EOQ 2025-05-30

Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)

Applicant Olympus Medical Systems Corporation

K-Number K250957

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LNH 2025-05-30

Swoop® Portable MR Imaging® System (V2)

Applicant Hyperfine, Inc.

K-Number K250236

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