8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
INFUSION SETS #'S 124 & 142 PERSONAL
FDA 510(k)
FDA Class 2
·General Hospital
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAINLINE MAXIE HCG URINE PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ULTRACISION HARMONIC SCALPEL HANDPIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·December 17, 2007
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 14, 2012
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024