139 results
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29ms
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Sources: EU EUDAMED, US FDA
SEASPINE MONOPOLAR PROBE SYSYEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WINCO STRETCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·September 14, 2018
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730033161·TruFit™2.0 .018 R UR6 CONV CBT HG-GIN -10T 10DO...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730033932·TruFit™2.0 .018 R UR6 CONV CBT HG-GIN -10T 10DO...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707110222·TruFit™2.0 .018 R UR6 CONV CBT HG-GIN -10T 10DO...
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
LUMENIS
FDA Adverse Event
Injury
·LUMENIS INC.·Product code GEX·May 8, 2013
VPAP SV
FDA Adverse Event
Death
·RESMED LTD.·Product code MNS·May 27, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730054371·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730035110·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730054333·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730035066·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit™ 2.0
FDA UDI
Ortho Organizers, Inc.·00190707115555·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730035004·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707160319·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730035059·TruFit™ 2.0 ASM .018 ROTH UR6 CONV CBT -10T 10D...