18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ilumien Optis, Optis Integrated, Optis Mobile
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578051·CoRoent Ant TLIF PEEK, 8x13x32mm 0°
Vanguard® SSK Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304440333·
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18054242519010·SHORT SCREWDRIVER
SYNTHES XRL
FDA 510(k)
FDA Class 2
·Orthopedic
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·December 6, 2021
LOW PRESSURE BLACK MAX HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 17, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·June 21, 2013
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 28, 2011
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EYB·July 2, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 28, 2022
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code EZL·July 8, 2022
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023
BD PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·January 15, 2021
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015