11 results
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18ms
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Sources: EU EUDAMED, US FDA
NSI CARBON DIOXIDE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MGB Alert HSV1 Probe Mix, 48 rxn ASR, Finished Product
FDA UDI
Elitechgroup Mdx LLC·03661540952012·MGB Alert HSV-1 Probe Mix is an analyte specifi...
MGB Alert HSV-1 Probe Mix ASR, 09N44-002
FDA UDI
Elitechgroup Mdx LLC·03661540950070·MGB Alert® HSV 1 & 2 Probe Mix is an analyte sp...
Swivel Blade
FDA UDI
KOROS U.S.A., INC.·10840199537324·Mini Swivel Blade 16 x 33mm Deep, 45mm Wide
ACUMED
FDA UDI
Acumed LLC·10806378043222·Acutrak® Screw Removal Tray Assy
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS XCHF TYPE B180Y1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 8, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2012
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 12, 2010
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