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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.

Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn

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

Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

FDA Enforcement
Class II ·Terminated·Andover Healthcare Inc.·October 30, 2019

Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper

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

ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.

FDA Enforcement
Class II ·Terminated·ThyssenKrupp Access Corp·December 26, 2012

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

FDA Enforcement
Class II ·Terminated·Greiner Bio-One North America, Inc.·January 29, 2020

Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU

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

GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

FDA Enforcement
Class II ·Terminated·GE Healthcare·July 8, 2015

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

FDA Enforcement
Class II ·Terminated·Avid Medical, Inc.·March 25, 2020

PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

FDA Enforcement
Class II ·Terminated·Navilyst Medical, Inc·October 15, 2014

GEM Coupler Forceps, GEM4183C, packaged individually.

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 2, 2019