7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HYPO SUTURE
FDA 510(k)
FDA Class 2
·General Hospital
CURVED HEMOSTAT 5
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TANDEM E GCG VISUAL END POINT INNUMOENZ
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
MAMMOMARK, 11G MAMMOMARK II
FDA Adverse Event
Injury
·DEVICOR MEDICAL PRODUCTS, INC.·Product code NEU·November 8, 2012
LAMITRODE TRIPOLE 16C LEAD, 60CM
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 13, 2010
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
FDA Enforcement
Class II
·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020