13 results
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20ms
·
Sources: EU EUDAMED, US FDA
SUNLAMP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERA® Micro Ovd. Males Assorted (7)
FDA UDI
STERNGOLD DENTAL LLC·00841549100765·Resilient semi-precision attachment. Attachmen...
4CIS® Spinal System and 4CIS® Low Back System
FDA UDI
ALPHA AI CO.,LTD.·08800313887679·Rod Connector
4CIS SOLAR SPINE SYSTEM
FDA UDI
ALPHA AI CO.,LTD.·08806373532887·Rod connector, Axial
AURADONICS
FDA UDI
AURADONICS INC.·00810033835155·LATEX ELASTICS 3/16" 4.5 oz. - AMBER, 10000 ea....
MODIFICATION TO TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FORA POCT MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 27, 2012
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PUMP MMT-522LNAS PRDGM INS SK EN ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·August 10, 2010
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·September 29, 2021