9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ACTIVE CORTISOL DSL 2000-SP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ceramco® iC
FDA UDI
Dentsply International Inc.·D00148501410·
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Orthodontics Bracket
FDA 510(k)
FDA Class 2
·Dental
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·September 9, 2013
ACCU-CHEK AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code NBW·November 21, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
TOTALCARE-TREAT SURFACE&SCALE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·September 28, 2010
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018