SEO landing

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.

ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.

FDA Enforcement
Class II ·Terminated·Ellman International, Inc.·December 21, 2016

8.0cm Medium Attachment Product Usage: Pneumatic system

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

FDA Enforcement
Class II ·Terminated·Beaver Visitec·April 17, 2019

CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices

FDA Enforcement
Class II ·Terminated·Civco Medical Instruments Inc·July 18, 2012

WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.

FDA Enforcement
Class II ·Terminated·Teleflex Medical·December 21, 2016

Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.

FDA Enforcement
Class II ·Terminated·Surgical Tissue Network, Inc.·January 16, 2013

Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.

FDA Enforcement
Class II ·Terminated·Edwards Lifesciences, LLC·July 18, 2012

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

FDA Enforcement
Class II ·Terminated·Arrow International Inc·June 7, 2017

LARGE CRANIOTOME, BLACK MAX

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017