9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HEARTSTART 1000S
FDA 510(k)
FDA Class 3
·Cardiovascular
The Progressive Orthopaedic Company Total Knee System II
FDA 510(k)
FDA Class 2
·Orthopedic
HELIODENT PLUS
FDA 510(k)
FDA Class 2
·Dental
TITAN
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·December 14, 2021
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 20, 2014
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FNL·October 20, 2010
8.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·December 21, 2012
CE MED HGT TE W/SUT TABS
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·November 13, 2023
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024