34 results
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37ms
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Sources: EU EUDAMED, US FDA
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
FDA 510(k)
FDA Class 2
·Dental
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964004726·The ENDO CARRY-ON Procedure Kit contains all of...
Non-Telescopic PenEvac
FDA UDI
I.C. MEDICAL, INC.·00817688022602·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659258082·TI Humeral locking plate 110mm,5 holes _x000D_...
TI Humeral locking plate 150mm,9 holes
FDA UDI
mahe medical gmbh·EMAH10005800090·TI Humeral locking plate 150mm,9 holes
Powerheart® MDLink
FDA UDI
Zoll Medical Corporation·00812394021499·MDLink SW 12.0
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659258112·TI Humeral locking plate 150mm,9 holes _x000D_...
TI Humeral locking plate 110mm,5 holes
FDA UDI
mahe medical gmbh·EMAH10005800050·TI Humeral locking plate 110mm,5 holes
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659258068·TI Humeral locking plate 90mm,3 holes _x000D_...
TI Humeral locking plate 90mm,3 holes
FDA UDI
mahe medical gmbh·EMAH10005800030·TI Humeral locking plate 90mm,3 holes
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 31, 2025
TUFF PRO IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 31, 2025
ASNIS III CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·March 12, 2013
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·February 1, 2011
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·February 15, 2008
4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HTW·January 3, 2017
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015