32 results · 25ms · Sources: EU EUDAMED, US FDA

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CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P

FDA 510(k)
FDA Class 2 ·Anesthesiology

Bur PM2-70 80K FC Ø2.5x80 St

FDA UDI
Bien-Air Surgery SA·17630055519839·

Oticon

FDA UDI
Oticon A/S·05707131164216·K14, RITE CNB

NITANIUM® SUPER ELASTIC ARCHWIRES

FDA UDI
Ortho Organizers, Inc.·00190707060183·.020 LOWER NITANIUM® SUPER ELASTIC OVAL ARCH FO...

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383501156·Gutta Percha Points is used to root canal filin...

ENDOSKELETON® TCS

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00191375032069·Rigid Container System Tray

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·December 13, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·February 19, 2019

MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORTHOCEPH OC100 D

FDA 510(k)
FDA Class 2 ·Dental

ALERE DETERMINE HIV-1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·December 3, 2019

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 3, 2013

GRANUFLO

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

FDA Adverse Event
Injury ·DEXCOM, INC.·Product code MDS·May 2, 2011

THROMBUSTER II

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code MMY·March 17, 2014

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

SPYSCOPE DS II ACCESS & DELIVERY CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

THROMBUSTER II

FDA Adverse Event
Malfunction ·KANEKA CORPORATION·Product code DXE·October 23, 2012

THROMBUSTER II

FDA Adverse Event
Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

THROMBUSTER II

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code DXE·January 16, 2019