8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DIZZYFIX
FDA 510(k)
FDA Unclassified
·Unknown
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
FDA 510(k)
FDA Class 2
·Cardiovascular
FOSSA URETERAL STONE SWEEPER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOMECHOICE CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 13, 2011
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 25, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018