12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biomet Microfixation Sternal Closure System
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·January 10, 2019
MASIMO LNCS/M-LNCS OXIMETRY SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
FDA 510(k)
FDA Class 2
·Cardiovascular
LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·March 11, 2017
SMARTSET GMV 40G US EO
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·July 11, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
CORAIL AMT COLLAR SIZE 11
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code KWY·October 10, 2014
NEXUS AND NXT DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·April 21, 2009