13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Bicera Resorbable Bone Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 15, 2002
PVS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM VERIO
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 18, 2017
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
URETEX TO2 URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·April 24, 2013
QUANTUM TTC ESOPHAGEAL BALLOON DILATOR
FDA Adverse Event
Malfunction
·WILSON-COOK MED INC·Product code KNQ·June 24, 2011
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 3, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 2, 2020
FLEXOR URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Malfunction
·COOK INC·Product code FED·January 7, 2020
IPSOGEN JAK2 PCR KIT IVD
FDA Adverse Event
QIAGEN GMBH·Product code PSU·September 4, 2018
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025