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.
BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
FDA Enforcement
Class II
·Terminated·COVIDIEN MEDTRONIC·May 23, 2018
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
FDA Enforcement
Class II
·Terminated·Draegar Medical Systems, Inc.·May 23, 2018
Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy America Inc·May 22, 2013
Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
FDA Enforcement
Class II
·Terminated·Alden Optical·March 21, 2018
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 12, 2012
Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
FDA Enforcement
Class II
·Terminated·Alden Optical·March 21, 2018
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 25, 2018
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·January 25, 2017