9 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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AMIZYME-LEISHMANIA SPP. TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340348256·SS NON-LOCKING SCREW L26MM D5MM
SOLE MEDIAL COLUMN FUSION PLATE
FDA UDI
ORTHOFIX SRL·18053340347099·SS NON-LOCKING SCREW L26MM D5MM STERILE
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Visby Medical Respiratory Health Test
FDA 510(k)
FDA Class 2
·Microbiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2014
MODULAR ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·November 21, 2012
PFC SIG RPF INS SZ 3 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 17, 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