9 results
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18ms
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Sources: EU EUDAMED, US FDA
BCM-302 COLLIMATING CONE & COMPENSATIN
FDA 510(k)
FDA Class 1
·Immunology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137657·
PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601
FDA 510(k)
FDA Class 2
·Radiology
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series
FDA 510(k)
FDA Class 2
·Anesthesiology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014
UNK HIP FEMORAL HEAD METAL ASR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·October 23, 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·May 28, 2015
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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