9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
COULTER Z 1
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150652·K-WIRE - SINGLE TROCAR THREADED 2.0mm DIA x 200mm
Laminoplasty
FDA UDI
Seaspine Orthopedics Corporation·10889981062118·Plate Sizing Trial, 8mm L
Sensor Medical Single Use Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
FDA 510(k)
FDA Class 2
·Immunology
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·June 30, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·February 9, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 7, 2011
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