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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.

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

FDA Enforcement
Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·July 18, 2018

Fuse 1C Colonoscope

FDA Enforcement
Class II ·Terminated·EndoChoice, Inc.·February 3, 2016

BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

FDA Enforcement
Class I ·Terminated·Philips North America, LLC·April 5, 2017

DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

FDA Enforcement
Class II ·Terminated·Endologix·January 25, 2017

Left Atrial Catheter Set

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 21, 2018