10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUSTIM
FDA 510(k)
FDA Unclassified
·Unknown
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 3, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·July 19, 2012
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 30, 2010
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 3, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 6, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 9, 2012
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. 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