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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.

32667510(k)
944PMA
10475Companies
9261Trials

Latest Trends

During this period, 32667 medical devices received FDA 510(k) clearance and 944 devices received Premarket Approval (PMA) . Top categories: LLZ (807 devices), GEX (629 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-2729-2026

Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral o

Reason Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103,

Firm Orthofix U.S. LLC

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Class IIZ-2725-2026

Rapid Refill Continuous Injection System, UPN M00566001

Reason Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is

Firm Boston Scientific Corporation

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Class IIZ-2814-2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve B

Reason Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solut

Firm Windstone Medical Packaging, Inc.

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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-2818-2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Re

Reason Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solut

Firm Windstone Medical Packaging, Inc.

View on FDA →
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