10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TDX REA IRON/TIBC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106646·KIT, M-FAK
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776338282·Fukuda Style Shoulder Retractor
IVAC 811Y ELEC. CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
DRUG ACCESS SPIKE
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 5, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 29, 2012
PHILOS II DR
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·September 23, 2010
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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