35 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safco NiTi RL Rotary Files
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310208093·Safco NiTi RL rotary files, #35, (0.4 taper / 2...
32mm Glenosphere and Humeral Cup
FDA UDI
FX SOLUTIONS·03701037309377·HUMERAL CUP STANDARD PE/TA6V Ø32/+9
FX V135 Shoulder Prosthesis
FDA UDI
FX SOLUTIONS·03701037315293·FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø...
Single Use Biliary Stent V
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170186172·
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 27, 2026
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 22, 2026
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 22, 2026
BRACE EZE
FDA 510(k)
FDA Class 1
·Dental
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
FDA 510(k)
FDA Class 2
·Cardiovascular
BD INSYTE AUTOGUARD BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 16, 2026
BD INSYTE AUTOGUARD BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 16, 2026
PARAPAC 'MEDIC' (K020899)
FDA Adverse Event
Death
·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004
BD INSYTE AUTOGUARD BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·March 17, 2026
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013