20 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536858·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536841·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361013136·PedFuse Remind LES, Quad-H, 7.0mm x 75mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536872·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536889·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536865·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033536896·
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·February 20, 2015
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·February 27, 2015
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·March 9, 2015
TI-REPLICA HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
HYCARE LATEX EXAMINATION GLOVE, POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2
FDA Adverse Event
Injury
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code BSP·October 4, 2018
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 12, 2014
ACCENT DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
ENDURON NEUT 54OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·March 14, 2008
BD NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2
FDA Adverse Event
Injury
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code BSP·August 1, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018