11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HISTOPLASMA YEAST ANTI #CF10021X
FDA 510(k)
FDA Class 2
·Microbiology
Walgreens
FDA UDI
WALGREEN CO.·00311917199306·WALGREENS INFRARED EAR THERMOMETER /1 UNIT
ELEKTA NEUROMAG WITH MAXFILTER
FDA 510(k)
FDA Class 2
·Neurology
INFINITY Total Ankle System, INBONE Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·January 15, 2014
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·October 15, 2012
100%SILICONE 2WAY 5CC 16FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code EZL·May 21, 2015
F6 DIALYZER FINISHED ASSY (CASE)
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code MSE·August 6, 2010
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FPA·December 24, 2013
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