18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CentriMag Pre-connected Pack
FDA 510(k)
FDA Class 2
·Cardiovascular
Sonic
FDA UDI
Sonic Innovations, Inc.·05714464007158·SONIC RADIANT 100 MNR T R BL DEMO
HEALIX ADVANCE ORTHOCORD
FDA UDI
Medos International Sàrl·10886705021338·HEALIX ADVANCE BR ANCHOR w/ORTHOCORD TCP/PLGA A...
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENLUXTRA HUMIFIBER WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code MAI·January 4, 2018
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·November 3, 2014
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·August 24, 2011
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 2, 2018
5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·February 3, 2016
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·July 17, 2018
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·March 4, 2019
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 24, 2019
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 23, 2019
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code GEI·January 24, 2019
5.5 HEALIX ADVANCE BR W/OCORD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 23, 2019
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014