11 results
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19ms
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Sources: EU EUDAMED, US FDA
DURAZYME GOT/AST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257003169·***DISC***M2 ACT OA BRACE, LT VARUS,
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDI
THD SPA·08033737710609·The Light-Score LED rectoscope is a disposable ...
Opaque
FDA UDI
Kerr Corporation·00841396107924·Resin Based Dental Restorative Material - B2
ACUMED
FDA UDI
Acumed LLC·10806378040009·Fibula Rod Screw Caddy
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·May 8, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
PISCES QUAD PLUS
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code LGW·August 11, 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