11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Kodiak C Spinal Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038738·
Pressure Sentinel®
FDA UDI
Zimmer, Inc.·00889024038745·
IMAGE WORKS PANOURA
FDA 510(k)
FDA Class 2
·Dental
DUOPRO SAFETY SYRINGE (DUOPROSS)
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
TEMA ELBOW SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
BRILLANCE 64
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·August 9, 2011
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·July 12, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014