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

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ADVIA CHEMISTRY ENZYMATIC CREATININE_2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FLEXLINE CLAMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

BUFFLIGHT CLT SURGICAL LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

FLEXIBLE FABRIC EXTRA-LARGE BANDAGES

FDA Adverse Event
Injury ·UP&UP (TARGET BRAND) / TARGET GENERAL MERCHANDISE INC.·Product code KGX·June 28, 2022

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

BARD FLAT MESH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 15, 2013

ARCHITECT TOTAL B-HCG

FDA Adverse Event
Malfunction ·A.I.D.D LONGFORD·Product code DHA·April 27, 2011

PULMONETIC

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC.·Product code CBK·July 1, 2008

DREAMSTATION CPAP

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code BZD·January 16, 2025

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

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015

INRATIO2 PT MONITORING SYSTEM

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2016