54 results · 29ms · Sources: EU EUDAMED, US FDA

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UNIDUS MAGNUM MALE LATEX CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO INC·Product code GJS·October 26, 2010

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code GJS·June 3, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2011

INRATIO

FDA Adverse Event
Other ·ALERE SAN DIEGO, INC.·Product code GJS·October 26, 2010

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 31, 2011

ATTAIN OTW

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code JPA·May 10, 2010

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2012

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code GJS·May 10, 2010

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015

DAILIES TOTAL 1

FDA Adverse Event
CIBA VISION GMBH·Product code MVN·February 8, 2013

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024