11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Barrier EasyWarm Active Self-Warming Blanket
FDA 510(k)
FDA Class 2
·Cardiovascular
Sklar®
FDA UDI
SKLAR CORPORATION·10649111352164·SKLARLITE XD KELLY CVD 5.5"
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
FDA 510(k)
FDA Class 2
·Microbiology
Hemo-Lyte C Cartridge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
TRI-LOCK BPS SZ 5 STD OFFSET
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·September 2, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2013
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·January 3, 2025
GYNECARE GYNEMESH M UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAL·January 3, 2025
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