12 results
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18ms
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Sources: EU EUDAMED, US FDA
IMMUNOGLOBULIN G REAGENT SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDI
THD SPA·08033737710630·The Light-Score LED rectoscope is a disposable ...
ACUMED
FDA UDI
Acumed LLC·10806378040023·Universal Tray Assembly
Opaque
FDA UDI
Kerr Corporation·00841396107955·Resin Based Dental Restorative Material - C1
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D90980011916·MATHIEU NEEDLE HOLDER W/ SAFETY LATCH - HOOK TIP
ADP,1,P800,(2)S800,1/4" N,RESP. 3000,3
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828118576·ADP,1,P800,(2)S800,1/4" N,RESP. 3000,3
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARSCAN
FDA 510(k)
FDA Class 2
·Radiology
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR·Product code GEI·August 10, 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