9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SCISSORS 6 & 1/2 SHARP/BLUNT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHREX MIXING AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
FDA 510(k)
FDA Class 2
·Radiology
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code GZB·October 25, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·August 9, 2007
LS LF REG EXT SET NON-DEHP
FDA Adverse Event
Malfunction
·HOSPIRA, LTD·Product code FPK·April 16, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025