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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ClearPoint System and Accessories

FDA 510(k)
FDA Class 2 ·Neurology

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040187807·ZIRLUX ML DISC OM2 98x18

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112649·BARRON CORNEAL PUNCH 8.25MM

DEBAKEY NEEDLE PULLING FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896059542·DEBAKEY NEEDLE PULLING TISSUE FORCEPS TUNGSTEN ...

NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M

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

BLADEWORKS MICROKERATOME BLADE, MODEL 7061

FDA 510(k)
FDA Class 1 ·Ophthalmic

Clarius Ultrasound Scanner

FDA UDI
Clarius Mobile Health Corp·07540205001240·Portable Ultrasound Scanner

VITROS 250 CHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·October 15, 2008

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 10, 2011

EDWARDS SAPIEN TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 1, 2013

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

SUPER SHEATH

FDA Adverse Event
Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code LXH·September 24, 2018

ECCENTRICAL GLENOSPHERE DIA. 40 MM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A·Product code MBF·December 19, 2022

SUTURE ANCHOR, PEEK CORKSCREW FT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·September 24, 2018

SUTURE ANCHOR, PEEK CORKSCREW FT

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code HWC·September 24, 2018