11 results
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23ms
·
Sources: EU EUDAMED, US FDA
FLO TEM II (BLOOD/FLUID WARMER
FDA 510(k)
FDA Class 2
·General Hospital
Bioplate®
FDA UDI
Bioplate, Inc.·M3848131610·Straight Plate - Ø1.9 mm - 16 hole - 86 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813161CP1·Straight Plate - Ø1.9 mm - 16 hole - 86 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813161US0·Straight Plate - Ø1.9 mm - 16 hole - 86 mm
SnapShot Freeze 2
FDA 510(k)
FDA Class 2
·Radiology
HUMIDIFIER W/ OR W/OUT ADAPTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 18, 2010
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 7MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 29, 2024
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