8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUICKIE CARBON WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
DENTIN BONDING AGENT
FDA 510(k)
FDA Class 2
·Dental
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
MODIFIED KUGEL PATCH
FDA Adverse Event
Malfunction
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·January 10, 2013
TENDRIL DX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code NVN·January 15, 2014
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
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025