327 results · 23ms · Sources: EU EUDAMED, US FDA

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REPROCESSED SOFT TISSUE ABLATORS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673174·LEVAMED STABILI-TRI ANK BLU R I

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040133286·Zirlux TR A4 98x22mm

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648178528·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648178498·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648178511·Omnilink Elite Vascular Balloon-Expandable Sten...

Omnilink Elite

FDA UDI
ABBOTT VASCULAR INC.·08717648178504·Omnilink Elite Vascular Balloon-Expandable Sten...

Kalitec Disc Prep

FDA UDI
Kalitec Direct LLC·B07319K0162310·Bone Funnel, Wedged

NEMIO

FDA 510(k)
FDA Class 2 ·Radiology

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

FDA 510(k)
FDA Class 2 ·Neurology

GLIDEWELL HT IMPLANT

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 30, 2025

DISPOSABLE LAPCLINCH GRASPER TIP

FDA Adverse Event
Other ·MICROLINE SURGICAL INC.·Product code GEI·March 15, 2013

PROXIMATE** SKIN STAPLER 35 WIDE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 10, 2011

IDC-INTERLOCKING DETACHABLE COIL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORK LTD·Product code HCG·March 10, 2008

Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1

FDA Recall
Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025

INSET II

FDA Adverse Event
Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 4, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 10, 2024