15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197082709·WEBSTER TC Needle holder, straight
130mm,...
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019
IDEAL LIFE POD (MODEL ILP 0001)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TINA-QUANT FERRITIN GEN. 4
FDA 510(k)
FDA Class 2
·Immunology
GM HELIX IMPLANT 6.0X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019
GM HELIX IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019
GM HELIX ACQUA IMPLANT 6.0X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 27, 2011
GM HELIX IMPLANT 6.0X8
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019
CARTO 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·December 14, 2023
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026