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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.

Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·March 20, 2019

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.

FDA Enforcement
Class II ·Terminated·Merge Healthcare, Inc.·December 21, 2016

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

FDA Enforcement
Class II ·Terminated·Cell Marque Corporation·June 7, 2017

8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

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

Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

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

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·January 16, 2013

InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·July 18, 2012

AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system

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

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

FDA Enforcement
Class III ·Terminated·Siemens Healthcare Diagnostics·January 16, 2013

Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

FDA Enforcement
Class II ·Terminated·Epimed International, Inc.·July 31, 2019