8 results
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19ms
·
Sources: EU EUDAMED, US FDA
BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
WORRELL PATELLA TEMPLATE
FDA 510(k)
FDA Class 1
·Orthopedic
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
FDA 510(k)
FDA Class 1
·Physical Medicine
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 15, 2010
CARBIDE BURS - FG 557SU
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code EJL·December 11, 2012
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020