9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ultrasound System 1300
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
ACUMED WRIST SPANNING PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
FDA 510(k)
FDA Class 2
·Radiology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 1, 2011
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·August 19, 2008
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code CGA·July 15, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022