9 results
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26ms
·
Sources: EU EUDAMED, US FDA
4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889981058760·Pacifica Trial, 9mm x 20mm x 16mm
SeaSpine Spacer System - Pacifica™
FDA UDI
Seaspine Orthopedics Corporation·10889910058762·Pacifica Trial, 9mm x 20mm x 16mm
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
TP Pivot Pro Needle Guide
FDA 510(k)
FDA Class 2
·Radiology
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 29, 2013
SENTINOL NITINOL BILLARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·December 20, 2010
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 14, 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