9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
ORWO X-RAY FILM
FDA 510(k)
FDA Class 1
·Radiology
Klarity SRS Baseplate, Klarity Promise Baseplate
FDA 510(k)
FDA Class 2
·Radiology
TIPOWER POWERDRIVE AND RIMPOWER X & SX
FDA 510(k)
FDA Class 2
·Physical Medicine
INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 13, 2020
3.5MM TI CANCELLOUS POLYAXIAL
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNI·December 7, 2010
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012
EU 4.5X22MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·August 25, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021