11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MJ NEONATAL PERCUSSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·February 20, 2019
SCREWDRIVER 2.5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 4, 2011
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
FDA 510(k)
FDA Class 2
·Microbiology
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
XACT CAROTID STENT SYSTEM 10-8MMX40MM
FDA Adverse Event
Death
·EMBOSHIELD NAV·Product code NIM·August 17, 2010
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024