7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVACE Electrosurgical Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +
FDA 510(k)
FDA Class 2
·Orthopedic
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 13, 2008
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 22, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023