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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.

33070510(k)
948PMA
10562Companies
11087Trials

Latest Trends

During this period, 33070 medical devices received FDA 510(k) clearance and 948 devices received Premarket Approval (PMA) . Top categories: LLZ (814 devices), GEX (643 devices), GEI (589 devices). Most active applicants: Siemens Medical Solutions USA, Inc. (254), Boston Scientific Corporation (183), Arthrex, Inc. (174).

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-3183-2026

REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOL

Reason Reusable access port system may crack or seperate during use.

Firm Stryker Sustainability Solutions

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Class IIZ-3057-2026

Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1

Reason The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potentia

Firm Medline Industries, LP

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Class IIZ-3029-2026

Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98203

Reason Kits contain a potentially contaminated component which were recalled by the manufacturer

Firm Medline Industries, LP

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Class IIZ-3191-2026

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000

Reason Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically tra

Firm Datex-Ohmeda, Inc.

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Class IIZ-3046-2026

Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item

Reason The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling

Firm AVID Medical, Inc.

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Class IIZ-3047-2026

STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;

Reason A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identi

Firm Diagnostica Stago, Inc.

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