10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AGILON® XO Shoulder Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776170066·MIYA HOOK LIG CARRIER .
DEPUY ATTUNE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
M2A-MAGNUM MOD HD SZ 42MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 26, 2008
ACHIEVE MAPPING CATHETER - 20 MM
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·April 5, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025