93 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809841701·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE MEDIUM...
Imola-Silverstone
FDA UDI
Altus Spine, LLC·00843210133706·Shaver Distractor, 07mm
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193103334·HA PEEK EVOS Curved, , 7mmx10mmx 26mm , FLAT 0 ...
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Cardiovascular
RHS HELMET
FDA 510(k)
FDA Class 2
·Neurology
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·October 31, 2025
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 19, 2026
ENDEAVOR SPRINT OTW
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·April 11, 2013
TLS3 104C, THERMAL LIGATING SHEARS
FDA Adverse Event
Malfunction
·STARION INSTRUMENTS·Product code GEI·March 2, 2011
INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYB·May 21, 2008
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 1, 2026
QUIK-COMBO PACING/DEFIBRILLATION/ECG
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·May 14, 2026
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·December 9, 2025
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·December 22, 2025
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·April 3, 2026
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·November 4, 2025
ARCHITECT CA19-9XR
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·December 22, 2025
ALINITY I CA 19-9XR REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code NIG·July 29, 2025