11 results
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19ms
·
Sources: EU EUDAMED, US FDA
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI
FDA 510(k)
FDA Class 2
·Dental
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111190·
14Fr Low Profile Introducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
CharmFlex
FDA 510(k)
FDA Class 2
·Dental
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
FDA Enforcement
Class II
·Terminated·Implantech Associates Inc·February 26, 2014
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
FDA Recall
Terminated
·Implantech Associates Inc·Product code HST·January 29, 2014
ON-Q SILVERSOAKER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·September 5, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·October 4, 2010
OSVII LP TWO PIECE SHUNT SYSTEM WITH UNITIZED 11
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES IMPLANTS SA·Product code JXG·November 14, 2012
PORTEX
FDA Adverse Event
Malfunction
·ST PAUL·Product code JOH·January 21, 2021