15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VPS Impression Material
FDA 510(k)
FDA Class 2
·Dental
AQUACEL AG SURGICAL
FDA 510(k)
FDA Unclassified
·Unknown
NIOX MINO MODEL 09-1000
FDA 510(k)
FDA Class 2
·Clinical Toxicology
1049092-2018-00287
FDA Adverse Event
Injury
·Product code FRO·May 15, 2018
9618003-2021-01239
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 21, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013
AXIUS CORONARY SHUNT 1.75 MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·July 19, 2011
Dressing, wound, drug
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021
FLIPCUTTER II, SHORT, 9 MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MDM·May 12, 2017
9618003-2021-01006
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021
9618003-2021-01210
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
Dressing, wound, drug
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022
9618003-2022-00003
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·January 6, 2022
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