9 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
FDA 510(k)
FDA Class 2
·Cardiovascular
AUDIT MICROCV HS-CRP LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·June 29, 2011
PRIDE
FDA Adverse Event
Other
·PRIDE MOBILITY PRODUCTS CORP.·Product code ITI·September 2, 2008
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
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