9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SERO/TEX MONO TEST
FDA 510(k)
FDA Class 2
·Immunology
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268213861·CUSTOM SURGICAL KIT VEIN PACK
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268213860·CUSTOM SURGICAL KIT VEIN PACK
POLY STAT HCG DIPSTICK TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PERF-GEN Pulsatile Perfusion Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIPER2 STRAIGHT ROD480MM, COCR
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·May 20, 2014
UNKNOWN RIGHT HIP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 23, 2012
LIFEWEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 25, 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