14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OR3O Dual Mobility System
FDA 510(k)
FDA Class 2
·Orthopedic
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423751·Dela rosa Arch forming pliers with grooves/Wire...
N/A
FDA UDI
Medos International Sàrl·10886705032389·
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 25, 2015
Rhythmlink®
FDA UDI
RHYTHMLINK INTERNATIONAL, LLC·00816312024982·10 Injectable Monopolar Needle Electrodes, EMG,...
SMK, CX, CXE, RCN
FDA 510(k)
FDA Class 2
·Neurology
ZOLL Propaq M
FDA 510(k)
FDA Class 2
·Cardiovascular
Chalgren
FDA UDI
CHALGREN ENTERPRISES·00816020020429·Injectable Monopolar Needle Electrode, EMG, 75m...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 20, 2024
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
REMB UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·November 11, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024