15 results · 37ms · Sources: EU EUDAMED, US FDA

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NESS L300

FDA 510(k)
FDA Class 2 ·Neurology

ENDOSCOPIC LIGHT SOURCE XL180/L3

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LONG LENGTH DYAX NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

RESPIRONICS

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 5, 2024

SYNCHRO GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009

ASR ACETABULAR IMPLANT 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 11, 2013

ITST INTERTROCHANTERIC ONE-PIECE NAIL CAP

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSB·March 1, 2011

VOYAGER RX CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·May 28, 2008

RESPIRONICS

FDA Adverse Event
Malfunction ·Product code MNT·May 19, 2021

SYNCHRO GUIDEWIRE

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

SYNCHRO GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

SYNCHRO GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

SYNCHRO2-14 SUPPORT STRAIGHT 215CM

FDA Adverse Event
Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012