151 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
FDA 510(k)
FDA Class 2
·Neurology
CTXA Hip Extended Reference Data
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...
TruForm
FDA UDI
Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120303321·Diamond, medium grit
Humelock Reversed Shoulder
FDA UDI
FX SOLUTIONS·03701037306345·HUMELOCK REVERSED EPIPHYSEAL RASP Ø32mm
NOGA CARDIAC NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDITHERM MED2000
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 2, 2011
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 8, 2012
9611451-2007-00333
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 13, 2007
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·January 20, 2010
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·June 27, 2017
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·January 14, 2009
SINGLE-HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 30, 2010
9611451-2007-00335
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 19, 2007
BUBBLE CPAP CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 5, 2011
INFANT LOW FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 3, 2012
BUBBLE CPAP SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 13, 2011
INFANT SWIVEL Y-PIECE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 28, 2010
INFANT BIAS FLOW BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 8, 2010