11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SmartPilot YpsoMate NS-A2.25
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Richard Wolf GmbH·04055207041819·PROBE Ø 5.0MM WL 450MM 450 mm WL, d=7 mm
ApneaRX Pro
FDA 510(k)
FDA Class 2
·Dental
Cyclops Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,6.0,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 28, 2023
IMP,TSV,6.0,8,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 8, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·August 24, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 23, 2013
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021