11 results · 22ms · Sources: EU EUDAMED, US FDA

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HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS

FDA 510(k)
FDA Class 2 ·Immunology

n/a

FDA UDI
Ortho Development Corporation·00822409075591·12/14 Press-Fit Broach 18x27

PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325

FDA 510(k)
FDA Class 2 ·General Hospital

ORTELIUS 800

FDA 510(k)
FDA Class 1 ·Orthopedic

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013

PUMP MMT-722NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008

HOMECHOICE PRO

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 9, 2011

VIASYS

FDA Adverse Event
Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

CANNULA & CATHETER

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

FDA Enforcement
Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018