16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General Hospital
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0106150·Trial, 26 x 15mm, 8 Degree, Tapered, Straight
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 27, 2008
LifeBand® Load-distributing Band
FDA UDI
Zoll Circulation, Inc.·10849111001806·Single-use chest compression band. (3 per pack...
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
CYCLOTEC AMT CTI TENS DEVICE
FDA 510(k)
FDA Class 2
·Neurology
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 4, 2008
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 4, 2008
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·June 18, 2008
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·July 31, 2008
INRATIO
FDA Adverse Event
Injury
·HEMOSENSE, INC.·Product code JPA·June 2, 2008
TI VECTRA(TM) PLATE 1 LEVEL/14MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code KWQ·April 22, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·April 14, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·July 1, 2008
BABY CONTROLLED WALL MOUNT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·June 23, 2010
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020