10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LITTMAN TUNABLE STETHOSCOPE 2136
FDA 510(k)
FDA Class 1
·Cardiovascular
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
FDA 510(k)
FDA Class 2
·Cardiovascular
J-Temp
FDA 510(k)
FDA Class 2
·Dental
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 16, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 20, 2014
RESOLUTE INTEGRITY OTW
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·November 7, 2012
AS50 INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2010
INSPIRE 8F DUAL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·January 9, 2026
INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024