9 results
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26ms
·
Sources: EU EUDAMED, US FDA
NMC CYCLER MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sterngold Implant System Bone Mill Guide Pin - TRU NP
FDA UDI
STERNGOLD DENTAL LLC·00841549119033·Used to remove an area of crestal bone around t...
LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
FDA 510(k)
FDA Class 2
·Neurology
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
PRODISC-C IMPLANT
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·November 19, 2010
AUTOGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 1, 2014
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015