21 results · 22ms · 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.

APEX Manual Wheelchair

FDA 510(k)
FDA Class 1 ·Physical Medicine

LoFric® Sense™

FDA UDI
Wellspect AB·07333387023182·Single Use Urinary Catheter with salt solution....

LoFric® Sense™

FDA UDI
Wellspect AB·07392532086489·Single Use Urinary Catheter with salt solution....

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1614250·16mm H x 14mm W x 25mm L x 0 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L161425120·16mm H x 14mm W x 25mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X16142580·16mm H x 14mm W x 25mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X161425120·16mm H x 14mm W x 25mm L x 12 degrees XLIF

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B167311614250·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B167321614250·

PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01

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

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

FDA 510(k)
FDA Class 2 ·Microbiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

ONE TOUCH BASIC

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code CFR·January 29, 1998

STEALTHSTATION® S7´

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·July 13, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020