9 results
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19ms
·
Sources: EU EUDAMED, US FDA
NORDICLAB TESTOSTERONE RIA TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105762·KIT, OCHO w' COMBAT GAUZE - BLK/GRY
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
BAYER ADVIA IMS SYSTEM; 200 + 3
FDA 510(k)
FDA Class 2
·Immunology
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 8, 2014
HEARTMATE II LVAS, EUROPE
FDA Adverse Event
Injury
·THORATEC CORP·Product code DSQ·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021