74 results
·
32ms
·
Sources: EU EUDAMED, US FDA
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902097881·ADAPTER 9112370 SIZING 16MM CYLINDER
CEN/180 MYO DILUENT
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414181288·Myoglobin Diluent - CENTAUR - CONS - 1x10mL
SOLARA JR. MANUAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
R3 XLPE ANTEVERTED LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
BE-PLS 2050
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 26, 2014
BE-PLS 2050 PERMENANT LIFE SUPPORT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KFM·March 6, 2014
BE-PLS 2050 PERMENANT LIFE SUPPORT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 27, 2014
HLS SET
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·August 18, 2025
TUBING SET
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·April 28, 2025
TUBING SET
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·April 28, 2025
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·January 20, 2026
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·January 20, 2026
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·May 14, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 23, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·May 25, 2011
BE-PLS 2050 PERMANENT LIFE SUPPORT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 20, 2014
BE-PLS 2050 PERMENANT LIFE SUPPORT
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 28, 2014
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·October 9, 2025
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·May 22, 2026