10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ASNIS GUIDED SCREW SYSTEMS
FDA 510(k)
FDA Class 1
·Ophthalmic
BANANA KNIFE - K841969-LABELING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAMELBACK HANDLE-K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
2.5MM & 4MM PROBE K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
MH1 MICROHOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
FDA 510(k)
FDA Class 2
·Cardiovascular
PUMP IN STYLE ORIGINAL BREAST PUMP
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·February 14, 2014
SHERPA BALANCED 6F GUIDE CATHETER
FDA Adverse Event
Injury
·MEDTORNIC, INC·Product code DQY·October 23, 2012
MAGIC 3 FEMALE INTERMITTENT CATHETER
FDA Adverse Event
Malfunction
·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022