7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEART NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
OPTIMA CT520
FDA 510(k)
FDA Class 2
·Radiology
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
FDA 510(k)
FDA Class 2
·Radiology
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·December 10, 2010
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·July 9, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022