534 results
·
23ms
·
Sources: EU EUDAMED, US FDA
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FORAMATRON V, MODEL D680
FDA 510(k)
FDA Unclassified
·Unknown
STEAM STERILIZATION INTERGRATOR
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 5, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 9, 2013
STRYKER PAIN PUMP
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS KALAMAZOO·Product code MEB·March 28, 2011
VITALITY 2 DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
OT ULTRA METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 27, 2011
PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. 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
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 3, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 6, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 1, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 16, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 19, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 22, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 30, 2010
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 2, 2011
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 12, 2011