10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMPI TAPE PATCHES
FDA 510(k)
FDA Class 1
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm
SAPPHIRE INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
SYNTHES CONTOURED SYNMESH SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 31, 2013
INJECTION GOLD PROBE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code KNS·December 29, 2010
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 17, 2014
NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 15, 2024
NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 16, 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