10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CUB DIS II DPOAE MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CoRoent
FDA UDI
Nuvasive, Inc.·00887517403575·CoRoent® XL, 14x18x60mm 10°
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981460·anteriors; shade BL2; mould CM2
OnePacs System
FDA 510(k)
FDA Class 2
·Radiology
TDS ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·April 8, 2021
TR BAND
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DXC·February 27, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·August 5, 2014
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020