10 results · 18ms · 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.

NORDICLAB FERRITIN IRMA TEST

FDA 510(k)
FDA Class 2 ·Immunology

VITROS

FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750001750·VITROS Chemistry Products BENZ Reagent

Polishers

FDA UDI
DFS - DIAMON GmbH·04057176147363·UPORAL D cup, pu: 2 pcs

MODIFICATION TO FETCH ASPIRATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES

FDA 510(k)
FDA Class 2 ·Orthopedic

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 23, 2012

ASR 300 SPIKED CUP SIZE 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·May 28, 2015

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