11 results
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28ms
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Sources: EU EUDAMED, US FDA
GOMCO CIRCUMCISION CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665584458·MIS Fenestrated Screw, Ø6.5 x 35mm, Ø5.5mm Rod
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668101346·DIAMOND MICROMETER TRIPLE
THE TERMINATOR
FDA 510(k)
FDA Class 1
·Physical Medicine
SUOENA AFFINITY (TM) MODEL #802
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTOSOFTÂ 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 31, 2024
FREEDOM S-C TIE OLIVETIP CH14
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code KOD·August 11, 2016
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·January 17, 2013
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·July 10, 2014
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