11 results · 23ms · Sources: EU EUDAMED, US FDA

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AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Flexitron

FDA UDI
Nucletron B.V.·08717213026957·Flexitron Transfer Tube for 4F Flexibles (4)

CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

FDA Adverse Event
Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014

TOKUYAMA M-BOND

FDA 510(k)
FDA Class 2 ·Dental

ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

GUARDIAN ROLLING WALKER

FDA Adverse Event
Malfunction ·A&E·Product code ITJ·November 4, 2008

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

CYCLESURE BIOLOGICAL INDICATOR

FDA Adverse Event
Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code FRC·August 13, 2008

Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018