13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cool Cassette 2 Size 7 Instrument Tray Pure Purple
FDA UDI
PRACTICON, INC.·00723896015803·Instrument tray for dental tools
Cool Cassette 2 Size 7 Instrument Tray Cool Coral
FDA UDI
PRACTICON, INC.·00723896015797·Instrument tray for dental tools
Cool Cassette 2 Size 7 Instrument Tray True Blue
FDA UDI
PRACTICON, INC.·00723896015780·Instrument tray for dental tools
Cool Cassette 2 Size 7 Instrument Tray Clean Green
FDA UDI
PRACTICON, INC.·00723896015773·Instrument tray for dental tools
Cool Cassette 2 Size 7 Instrument Tray Steel Gray
FDA UDI
PRACTICON, INC.·00723896015766·Instrument tray for dental tools
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 30, 2026
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018