534 results · 23ms · Sources: EU EUDAMED, US FDA

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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