9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOQTEQ® VA Elbow Plates 2.7/3.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020324·INTRG WHISP-Z ROTH ANT 0T 0A 022 LO
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
FDA 510(k)
FDA Class 2
·Cardiovascular
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 1, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 16, 2013
TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·October 27, 2019
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