9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
BD VENFLON¿ IV CANNULA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·October 21, 2019
PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PERFORATOR DRIVER WITH HUDSON END
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 14, 2014
STERNAL ZIPFIX W/NEEDLE PEEK 5U
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·June 15, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 21, 2011
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020