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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.

Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

FDA Enforcement
Class II ·Terminated·Aesculap, Inc.·February 20, 2013

Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa

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

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

FDA Enforcement
Class II ·Terminated·Cyberonics, Inc·May 6, 2015

Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM

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

Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

FDA Enforcement
Class II ·Terminated·Hologic, Inc·October 25, 2017

Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM

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

Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

FDA Enforcement
Class II ·Ongoing·Arrow International Inc·January 29, 2020

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 7, 2018

Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills

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

Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM

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