16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G223150719590·Crile Hemostatic Forceps Curved TW 2.0mm, OL 13...
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3 ML BD LUER-LOK LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·October 21, 2019
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTEC)·Product code NEW·November 14, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·April 22, 2013
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPP·April 19, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025