9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
HEPARINOMETER
FDA 510(k)
FDA Class 2
·Hematology
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099648806·AGILE NAIL TI LOCKING SCREW L24MM D4MM STERILE
HWJECT Auto-disable syringe
FDA 510(k)
FDA Class 2
·General Hospital
TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
FDA 510(k)
FDA Class 2
·Dental
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 27, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 15, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 14, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018