8 results
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25ms
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Sources: EU EUDAMED, US FDA
FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123
FDA 510(k)
FDA Class 1
·Hematology
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS MODEL MX 16 SLICE CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM LARGE TITANIUM LIGA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2007
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 14, 2012
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013