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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.

32542510(k)
942PMA
10444Companies
8681Trials

Latest Trends

During this period, 32542 medical devices received FDA 510(k) clearance and 942 devices received Premarket Approval (PMA) . Top categories: LLZ (805 devices), GEX (629 devices), GEI (582 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (252), Boston Scientific Corporation (181), Arthrex, Inc. (171).

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 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-2677-2026

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Reason Surgical dressing manufactured out of specification (greater thickness).

Firm ConvaTec, Inc

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Class IIZ-2755-2026

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a

Reason Boston Scientific's complaint investigations have identified that a subset of air ingress complaints

Firm Boston Scientific Corporation

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Class IIZ-2753-2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4

Reason Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is n

Firm Boston Scientific Corporation

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Class IZ-2682-2026

ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Intro

Reason A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, i

Firm Abiomed, Inc.

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