12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cortex Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028475·PESSARY, GELLHORN SHORT STEM #0, 1.50"
SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 28, 2019
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
MAXZERO EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 17, 2019
JOURNEY BCS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·July 6, 2011
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 6, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008