11 results · 19ms · Sources: EU EUDAMED, US FDA

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ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

FUSE ™ SPINAL SYSTEM

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169245501·CAGE 2881224 FUSE 12MM X 24MM 8DEG

dentaform®

FDA UDI
DENTAURUM GmbH & Co.KG·J011881224220·dentaform® Snap Band, Tooth 36, Size 24/Roth 22

dentaform®

FDA UDI
DENTAURUM GmbH & Co.KG·J011881224180·dentaform® Snap Band, Tooth 36, Size 24/Roth 18

dentaform®

FDA UDI
DENTAURUM GmbH & Co.KG·J011881224000·dentaform® Snap Band, Tooth 36, Size 24

METER, FLOW, PEAK

FDA 510(k)
FDA Class 2 ·Anesthesiology

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUF·Product code LXH·October 6, 2010

DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NVY·January 13, 2014

GYNECARE MORCELLEX* TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·December 20, 2012

Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

FDA Enforcement
Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013