11 results · 21ms · 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.

MEDTRONIC M2 MAGNET ADJUSTMENT TOOL

FDA 510(k)
FDA Class 2 ·Neurology

ACTICLOT PROTEIN S, MODEL 843L

FDA 510(k)
FDA Class 2 ·Hematology

POCKETCHEM UA AUTION STICKS 10TA

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

56MM AND R3 ACETABULAR SHELL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·September 14, 2018

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013

MULTI-LINK RX VISION CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 23, 2008

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 12, 2011

OXYSURE

FDA Adverse Event
Injury ·OXYSURE·Product code CAW·March 19, 2014

OXYSURE

FDA Adverse Event
Injury ·OXYSURE·Product code DQA·March 19, 2014

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

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012