24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fehling-Punches
FDA 510(k)
FDA Class 2
·Neurology
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161121532430·Crossbar Acetabular Reamer - 43mm
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 18, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
PROTECTIVE SAFETY IV CATHETER
FDA Adverse Event
Injury
·SMITHS MEDICAL NORTH AMERICA·Product code FOZ·June 30, 2011
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQE·September 5, 2008
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·April 27, 2022
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
SCREW,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·December 30, 2014
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
UNK - SCREWS: 2.7 MM VA LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 1, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 22, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 24, 2015