12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BINDAFIX
FDA 510(k)
FDA Class 1
·General Hospital
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198956·AK3 Congruent Insert Trial Size 2, 11mm
JOURNEY II Unicompartmental Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
HORIZON APPLIER SMALL WIDE 8" CURVED
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 5, 2010
Various ob/gyn packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various hysterectomy, vaginal packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various Laparoscopy Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022