13 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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SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172411·Potts-Smith Tissue Fcps serr teeth
ArgenZ HT+ 98x18 ML B3B
FDA UDI
ARGEN CORPORATION, THE·D818130357·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013742·RONIS MEASURING ROD MEASURING LENGTHS 3.5 MM, 4...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433347·Integra® Jarit® Potts-Smith Forceps, Tissue, 8-...
LIFEBRIDGE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUANTIX/OR DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·March 14, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2011
Single Shot Epidural Tray Catalog Number: 6183R1
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015