12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70606451·Sprint II Bracket Roth .018" 1000 Brackets 3 w....
AT HOME DRUG TEST, MODEL 9063 T
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 22, 2015
M2A 38MM MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 13, 2008
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·April 6, 2011
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023
EDWARDS LOCKING SYRINGE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018