10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VINT
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 26, 2020
CONTINUUM PACS
FDA 510(k)
FDA Class 2
·Radiology
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
1MM COARSE DIAMOND BALL, STD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025