12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Vantage PSI System
FDA 510(k)
FDA Class 2
·Orthopedic
ADVIA® Chemistry IGG_2 Reagents
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414513119·IgG - ADVIA Chem. - RGT - 4x90 tests
UNITY NETWORK ID
FDA 510(k)
FDA Class 2
·Cardiovascular
SHERPA PAK CARDIAC TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 23, 2025
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 7, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 27, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011
LASSOSTARNAV,10P,15MM DIA LOOP
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023
LASSOSTAR CATHETER
FDA Adverse Event
Death
·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020
LASSOSTAR NAV CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018