9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
FDA 510(k)
FDA Class 1
·Cardiovascular
CLEARCUT S SAFETY KNIFE
FDA 510(k)
FDA Class 1
·Ophthalmic
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 19, 2020
5 FR D/L POWERPICC SOLO FULL TRAY
FDA Adverse Event
Injury
·BARD ACCESS SYSTEMS·Product code LJS·April 29, 2014
LIGACLIP EXTRA TITANIUM CLIPS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 31, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC., USA·Product code LFR·October 12, 2007
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 1, 2022
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024