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FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

Toshiba Aquilion CT System TSX-301B

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·October 21, 2015

I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

FDA Enforcement
Class II ·Terminated·C.R. Bard, Inc.·December 27, 2017

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

FDA Enforcement
Class II ·Terminated·Carefusion 2200 Inc·April 25, 2018

Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.

FDA Enforcement
Class I ·Terminated·Alere San Diego, Inc.·July 18, 2012

Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·July 11, 2018

Toshiba Aquilion CT System TSX-301A

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·October 21, 2015

REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60

FDA Enforcement
Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·July 11, 2018

Toshiba Aquilion CT System TSX-303A

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·October 21, 2015

Synthes Trauma Nail System. The devices are indication for bone fixation.

FDA Enforcement
Class II ·Terminated·Synthes USA HQ, Inc.·September 4, 2013

ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020