12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Everest Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Ø3.5mm x 8mm Lateral Mass Screw with Set Screw
FDA UDI
XENCO MEDICAL LLC·B064XM21735081·Ø3.5mm x 8mm Lateral Mass Screw with Set Screw ...
UNMIAX LAPAROSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARKONE
FDA 510(k)
FDA Class 2
·Ophthalmic
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
S-ROM*SLEEVE PRX ZTT, 18B-LRG
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTC·February 4, 2022
ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTC·February 4, 2022
ALINITY S HBSAG REAGENT KIT
FDA Adverse Event
Injury
·ABBOTT IRELAND·Product code QHM·October 4, 2022
ALINITY S HBSAG REAGENT KIT
FDA Adverse Event
Injury
·ABBOTT IRELAND·Product code QHM·November 29, 2022
7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017