18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776182151·Cobb Curette angled size
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690125471·Modular Knee Stem Pilot 19mm x 100mm
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780184003·Integra® Jarit® Cobb Style Bone Curette, 11", H...
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361029472·Ø10MM X 90MM SLOTTED FUSION SCREW, GEN II, SACR...
ScalpelCric
FDA 510(k)
FDA Class 2
·Anesthesiology
NIGHT SHIFT
FDA 510(k)
FDA Class 2
·Dental
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 9, 2002
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 20, 2012
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code FRN·June 11, 2018
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 1, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 1, 2018
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 9, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013
DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/75MM
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code KTT·November 17, 2014
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 22, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025