9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANSPACH 65,000
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
8CM ANGLE ATTACHMENT, BLACK, MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 22, 2015
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·December 7, 2010
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 14, 2014
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024