22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129401·20-30 MV FOR MEN CLSC EW STD GREY VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128077·20-30 MV FOR MEN SEL EW CLF STD GREY VI
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052504·LERICHE Hemostatic Forceps
150mm,...
POWERPRESS UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTUM CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2022
MARISA
FDA Adverse Event
ARJO MED AB LTD·Product code FSA·May 24, 2013
UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 27, 2011
PARIETEX COMP 3D PY 25X20CM NO THRX1
FDA Adverse Event
Injury
·TREVOUX - USS·Product code FTL·August 29, 2008
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
MICRUSFRAME18 7MM X 14.3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
MICRUSFRAME10 7MM X 30CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 29, 2022
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 16, 2018