4,811 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROSURGEON'S CHAIR WITH 5" LIFT PISTON, 16" - 21" (HEIGHT RANGE PREFERRED BY M
FDA UDI
GLOBAL SURGICAL CORPORATION·00810040253669·
PRIDE MOBILITY PRODUCTS
FDA Adverse Event
Injury
·PRIDE MOBILITY PRODUCTS·Product code ITI·January 11, 2022
Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC·Product code MNT·October 29, 2015
PRIDE MOBILITY PRODUCTS
FDA Adverse Event
Injury
·PRIDE MOBILITY PRODUCTS·Product code INI·May 2, 2024
ENDOWRIST INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL INC.·Product code NAY·February 16, 2010
AQUAMANTYS 6.0 BIPOLAR SEALER
FDA Adverse Event
Other
·SALIENT SURGICAL TECHNOLOGIES, INC.·Product code GEI·June 26, 2009
ELEOS¿ LIMB SALVAGE SYSTEM
FDA Adverse Event
Injury
·ONKOS SURGICAL INC.·Product code KRO·December 8, 2025
ORTHO VISION ID-MTS
FDA Adverse Event
Malfunction
·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·November 21, 2017
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 9, 2019
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 9, 2019
UNKNOWN HIP ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 9, 2019
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MUM·February 27, 2009
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MUM·February 27, 2009
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MUM·February 27, 2009
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MUM·February 27, 2009
WALLFLEX ENTERAL DUODENAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code MUM·February 27, 2009
WEE CARE DIGITAL PACIFIER/THERMOMETER
FDA Adverse Event
Malfunction
·QUESTECH INTL, INC.·Product code FLL·April 23, 1996
ELEOS LIMB SALVAGE SYSTEM
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·April 9, 2024