10 results
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18ms
·
Sources: EU EUDAMED, US FDA
PERLINK SCREEN, KIRAN SCREEN
FDA 510(k)
FDA Class 1
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756694117·CYSTO PACK
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
FDA 510(k)
FDA Class 1
·Cardiovascular
DVM-4200 BLOOD FLOWMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LZO·June 29, 2023
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2014
ANTHEM RF
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
STD CRANIOTOME, BM
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HSZ·December 28, 2012
HEARTMATE 14 VOLT LITHIUM ION BATTERY SET
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·January 25, 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