7,380 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HBL Blade Assembly
FDA 510(k)
FDA Class 2
·Orthopedic
Fetal Doppler
FDA UDI
HATCH BABY, INC.·00866755000289·
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code NDN·April 21, 2017
AORFIX AAA FLEXIBLE STENT GRAFT
FDA Adverse Event
Injury
·LOMBARD MEDICAL LTD.·Product code MIH·May 13, 2016
AORFIX AAA STENT GRAFT
FDA Adverse Event
Injury
·LOMBARD MEDICAL LTD.·Product code MIH·April 22, 2016
Thermo Scientific
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693564410·Thermo Scientific HIER Buffer L
DIGIT WIDGET
FDA Adverse Event
Injury
·HAND BIOMECHANICS LAB, INC.·Product code JDW·April 18, 2018
AORFIX AAA FLEXIBLE STENT GRAFT
FDA Adverse Event
Injury
·LOMBARD MEDICAL LTD.·Product code MIH·May 5, 2016
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
FDA 510(k)
FDA Class 2
·Orthopedic
DIGIT WIDGET
FDA Adverse Event
Injury
·HAND BIOMECHANICS LAB·Product code JDW·March 17, 2026
PLATE BRUCELLA AGAR 5% HBL 90MM 20
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code KZI·April 19, 2023
AORFIX AAA FLEXIBLE STENT GRAFT
FDA Adverse Event
Death
·LOMBARD MEDICAL LTD.·Product code MIH·May 11, 2016
AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·LOMBARD MEDICAL LTD.·Product code MIH·October 2, 2014
AORFIX AAA FLEXIBLE STENT GRAFT
FDA Adverse Event
Injury
·LOMBARD MEDICAL LTD.·Product code MIH·January 6, 2016
AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·LOMBARD MEDICAL LTD.·Product code MIH·September 18, 2014
DIGIT WIDGET
FDA Adverse Event
Injury
·HAND BIOMECHANICS LAB, INC·Product code JDW·May 2, 2023
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
FDA Enforcement
Class II
·Terminated·Hand Biomechanics Lab Inc·October 26, 2016
AORFIX AAA FLEXIBLE STENT GRAFT
FDA Adverse Event
Injury
·LOMBARD MEDICAL LTD.·Product code MIH·February 19, 2016
DIGIT WIDGET
FDA Adverse Event
Injury
·HAND BIOMECHANICS LAB, INC·Product code JDW·September 17, 2024
DIGIT WIDGET
FDA Adverse Event
Injury
·HAND BIOMECHANICS LAB, INC·Product code JDW·August 14, 2024