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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: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - Spohn

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

Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

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

Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

iConnect Enterprise Archive software.

FDA Enforcement
Class II ·Terminated·Merge Healthcare, Inc.·April 5, 2017

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn

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

VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

FDA Enforcement
Class II ·Terminated·Medtronic Navigation, Inc.·October 25, 2017

Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa

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

OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

FDA Enforcement
Class II ·Terminated·OrthoPediatrics Corp·August 1, 2012