35 results · 24ms · Sources: EU EUDAMED, US FDA

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ARCHITECT STAT TROPONIN-I IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

K041492

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 18, 2021

SELF ADHERING NAVIGUS GUIDE

FDA 510(k)
FDA Class 2 ·Neurology

COMPRESSIBLE LIMB SLEEVE

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERTE-STACK K030736, K041197

FDA Adverse Event
Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

CORNERSTONE-SR CAGE SYSTEM

FDA Adverse Event
Death ·MSD DEGGENDORF MFG·Product code ODP·February 17, 2012

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 29, 2011

ACUITY

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·April 8, 2013

EASYTRAK

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·April 6, 2011

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 9, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 2, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 25, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 10, 2011

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 11, 2011