11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SQC BUFFER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18126011·
INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
FDA 510(k)
FDA Class 2
·Cardiovascular
SF SAF QUI+ UNDY 4/0 (1,5) 70 CM DS16 (M)
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·April 17, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 31, 2012
ADVIA CENTAUR RUBELLA G (RUB G) ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LFX·August 18, 2010
EDWARDS INSPIRIS RESILIA AORTIC VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·July 11, 2025
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·October 21, 2020
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
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