35 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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