10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SHARPE ENDOSCALPEL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EU 4.5X37MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 14, 2022
HLIC NEEDLE-LESS VALVE
FDA 510(k)
FDA Class 2
·General Hospital
FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 13, 2010
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012
EU 4.5X37MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·May 31, 2022
PROWLER SELECT PLUS 150/5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·August 8, 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