9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PRESSURE INFUSION PUMP
FDA 510(k)
FDA Class 1
·General Hospital
Pediatric Forceps - #27 Molar Bird Beak
FDA UDI
Denovo Dental, Inc.·00810059291935·Pediatric Forceps - #27 Molar Bird Beak
Bioplate®
FDA UDI
Bioplate, Inc.·M3848131050·1.5mm diam. Plate & Screw Container
Mimics Medical
FDA 510(k)
FDA Class 2
·Radiology
TEMPUSIC PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE
FDA Adverse Event
Injury
·DEPUY SYNTHES·Product code HRS·May 15, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
DELTA
FDA Adverse Event
Malfunction
·DRAGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·August 18, 2010
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