22 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131556·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131471·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131594·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131631·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131433·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131617·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131457·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131419·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131495·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131570·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131518·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304131532·
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
FDA 510(k)
FDA Class 3
·Orthopedic
POSSIS SUTURELESS MYOCARDIAL LEAD
FDA Adverse Event
Injury
·POSSIS MEDICAL, INC.·Product code LWS·November 17, 1995
AXON DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·March 1, 2013
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·July 21, 2014
ELECTRIC MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 3, 2011
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL 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