8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EZTEST-STEAM
FDA 510(k)
FDA Class 2
·General Hospital
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
FDA 510(k)
FDA Class 2
·Dental
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
FDA 510(k)
FDA Class 2
·Dental
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
NATURAL-KNEE II SYSTEM TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSH·December 14, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2014
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·January 4, 2017
Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code ETN·October 29, 2004