10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IL TEST BETA-2MICROGLOBULIN
FDA 510(k)
FDA Class 2
·Immunology
AMS ANA CARD
FDA 510(k)
FDA Class 1
·Microbiology
ARGILITE 4 GOLD ALLOY FOR PORCELAIN
FDA 510(k)
FDA Class 1
·Dental
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·February 5, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2014
BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 25, 2019
SHARPS DISPOSAL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 16, 2019
PKG, 3MM INSERT, BLUNT GRASPER, 29CM, P/N 0250282056 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020