9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
FIBER OPTIC LARYNGOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
OSCAR BONE RESECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
3-DAY BIOINDICATOR RELEASE PROCESS FOR
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 21, 2020
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 15, 2012
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·February 13, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MKJ·October 21, 2010
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 4, 2018
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020