17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Cool Cassette 2 Size 14 Instrument Tray Clean Green
FDA UDI
PRACTICON, INC.·00723896008997·Building on the success of the original Cool Ca...
Cool Cassette 2 Size 14 Instrument Tray Cool Coral
FDA UDI
PRACTICON, INC.·00723896008973·Building on the success of the original Cool Ca...
Cool Cassette 2 Size 14 Instrument Tray Pure Purple
FDA UDI
PRACTICON, INC.·00723896008980·Building on the success of the original Cool Ca...
Cool Cassette 2 Size 14 Instrument Tray True Blue
FDA UDI
PRACTICON, INC.·00723896008966·Building on the success of the original Cool Ca...
Cool Cassette 2 Size 14 Instrument Tray Steel Gray
FDA UDI
PRACTICON, INC.·00723896015759·Instrument tray for dental tools
Cool Cassette 2 Size 7 Instrument Tray Steel Gray
FDA UDI
PRACTICON, INC.·00723896015766·Instrument tray for dental tools
POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
FDA 510(k)
FDA Class 1
·General Hospital
ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 14, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 28, 2011
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 9, 2025
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
MICROVASCULAR PLUG
FDA Adverse Event
Injury
·REVERSE MEDICAL·Product code KRD·September 8, 2021
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