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FDA Medical Device Regulatory Records

Daily updated FDA 510(k) clearances, PMA approvals, clinical trial data, and biomedical literature from official government APIs. Free to search.

32732510(k)
945PMA
10489Companies
10003Trials

Latest Trends

During this period, 32732 medical devices received FDA 510(k) clearance and 945 devices received Premarket Approval (PMA) . Top categories: LLZ (809 devices), GEX (630 devices), GEI (582 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (181), Arthrex, Inc. (173).

Latest FDA PMA Approvals

Most recent Premarket Approval decisions

Latest FDA 510(k) Clearances

Most recent medical device clearances

View all FDA 510(k) Clearances

Latest PubMed Research

Recent medical device publications from PubMed / NCBI

FDA Medical Device Recalls

Latest recalls and safety alerts from FDA

Class IIIZ-2881-2026

Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390

Reason out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Cali

Firm Siemens Healthcare Diagnostics, Inc.

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Class IIZ-2914-2026

GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, se

Reason 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diamet

Firm W L Gore & Associates, Inc.

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Class IIZ-2945-2026

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Numbe

Reason Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected vari

Firm Cardinal Health 200, LLC

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Class IIZ-2885-2026

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and

Reason Due to an incomplete process of the component screw by a subcontractor which prevents the properly a

Firm United Orthopedic Corp.

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Class IIZ-2890-2026

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Reason Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depr

Firm Siemens Healthcare Diagnostics, Inc.

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Class IIZ-2857-2026

Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Ca

Reason Due to a defective circuit board that overheats

Firm Oxos Medical Inc

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