11 results · 21ms · Sources: EU EUDAMED, US FDA

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Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

FDA 510(k)
FDA Class 2 ·Ophthalmic

BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 24, 2020

MEDISIZE GOLD HEATER AND BOOSTER T-PIECE

FDA 510(k)
FDA Class 2 ·Anesthesiology

LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 12, 2020

FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

FDA Adverse Event
Malfunction ·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025

SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

FDA Adverse Event
Other ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·August 10, 2011

KION

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code BSZ·August 15, 2008

11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HSB·July 12, 2013

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

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