9 results · 19ms · 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.

BUFFERED CHARCOAL YEAST EXTRACT AGAR

FDA 510(k)
FDA Class 1 ·Microbiology

MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ONCOLOGY SALVAGE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RHK SEGMENTAL SHORT YOKE

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

SYMBIQ SINGLE CHANNEL

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014

ACCU-CHEK ® ADVANTAGE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2012

VERSA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 17, 2010

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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