31 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDOWRIST STAPLER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304204508·
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007074·GLOBAL ADVANTAGE POROCOAT STANDARD STEM SIZE 6 ...
GLOBAL ADVANTAGE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007067·GLOBAL ADVANTAGE STANDARD STEM SIZE 6 108mm
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·May 8, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 26, 2026
UNK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 26, 2026
ARCHITECT HAVAB-IGG
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·April 3, 2026
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PAO·September 29, 2017
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·September 29, 2017
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·May 1, 2014
FLEXTOME® CUTTING BALLOON®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 15, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 2, 2011
COMPREHENSIVE PT HYBRID GLEN POST REGENEREX
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·September 28, 2017
BIO-MOD HUM HEAD 44DIAX17MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·September 28, 2017
VERSA-DIAL/COMP TI STD TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·September 29, 2017
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·November 26, 2025
ALINITY I HAVAB IGG REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LOL·August 20, 2025