10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776084387·Henrotin Clamp
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
PRIMING SET FOR ARTERIAL BLOODLINES
FDA Adverse Event
Malfunction
·REYNOS MANUFACTURING·Product code KOC·May 13, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 1, 2010
ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 11MM X 150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 29, 2025
MAK ORTHOPEDIC SALVAGE SYSTEM RS DISTAL FEMORAL COMPONENT LEFT 8.5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·May 29, 2025
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