11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
3M BRAND RESTORATIVE Z100
FDA 510(k)
FDA Class 2
·Dental
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668110973·STERILIZING CASE MEDIUM/SMALL
Arthrex®
FDA UDI
ARTHREX, INC.·00888867058897·UNIVERS FRACTURE TRIAL STEM, SIZE 12
MAGNETOM Vida, MAGNETOM Sola
FDA 510(k)
FDA Class 2
·Radiology
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 10, 2010
IDENTITY ADX SR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 7, 2012
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025