15 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DUO-DENT DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
AEQ REV II GLENOID BASEPLATE DIA 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·July 1, 2025
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 13, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 6, 2025
PROCISE MAX
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·April 8, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 4, 2011
2017865-2008-01372
FDA Adverse Event
Malfunction
·Product code DTB·May 27, 2008
AEQUALIS REVERSED MULTIDIRECTIONAL GLENOID PLATE HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·March 25, 2024
D.4,5MM COMPRESSION SCREW L.32MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
D.4,5MM COMPRESSION SCREW L.23MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
AEQ REV GLENOID BASEPLATE 29MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 21, 2024
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012