12 results · 28ms · 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.

PREMIER-C. DIFFICILE TOXIN A

FDA 510(k)
FDA Class 1 ·Microbiology

Brigade

FDA UDI
Nuvasive, Inc.·00887517962683·Brigade Lateral Trial, 8x34x32mm 15°

BBIG

FDA UDI
BBig B.V.·08719616011714·4903456

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 4, 2024

THE SENSITITRE AIM

FDA 510(k)
FDA Class 2 ·Microbiology

JETSTREAM G3 SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DURASUL, ALPHA INSERT, II/36

FDA Adverse Event
Malfunction ·ZIMMER GMBH·Product code JDI·July 27, 2017

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·November 27, 2018

XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·June 30, 2014

VENTRICULAR ASSIST DEVICE

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·January 4, 2013

LP20

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·September 20, 2010

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