9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Padlock Clip defect closure system, Padlock Pro-Select defect closure device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GE DATEX-OHMEDA AVANCE
FDA 510(k)
FDA Class 2
·Anesthesiology
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
MP30 INTELLIVUE PT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 8, 2014
GRANUFLO ACID CONCENTRATE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 21, 2013
WORKHORSE II PTA BALLOON CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQY·July 11, 2011
UNKN FEM HEAD AARAU METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code LZO·November 16, 2021
UNKN. SL-PLUS STEM
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS AG·Product code FSM·November 16, 2021
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026