12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOW LIMITER
FDA 510(k)
FDA Class 1
·Anesthesiology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR17910171·Micro protrusion screw
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR17910170101·Micro protrusion screw
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR17910171001·Micro protrusion screw
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRESSURE MODULE (MODEL P3)
FDA 510(k)
FDA Class 2
·Cardiovascular
COBAS 8000 E 801 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 26, 2024
COBAS E 801 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 6, 2024
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
ATLAS II PLUS DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 5, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
COBAS E 801 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 18, 2024