26 results · 28ms · Sources: EU EUDAMED, US FDA

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CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040133194·Zirlux TR C4 98x18mm

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179198·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179174·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179204·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179167·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179181·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648179211·Omnilink Elite Vascular Balloon-Expandable Sten...

Claymount

FDA UDI
Varex Imaging Nederland B.V.·08718755000443·x-ray beam-limiting device, to restrict the dim...

BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 30, 2021

BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 30, 2021

AUTOSOFT XC

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·October 15, 2025

BIOSLEEP

FDA 510(k)
FDA Class 2 ·Neurology

PRESSURE TRAK, MODEL 222-B

FDA 510(k)
FDA Class 2 ·Cardiovascular

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 23, 2025

BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·June 1, 2021

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·February 21, 2013

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

CONSERVE PLUS CUP

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 10, 2008