9 results
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18ms
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Sources: EU EUDAMED, US FDA
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
FDA 510(k)
FDA Class 2
·Microbiology
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028555·3M™ Unitek™ Stainless Steel First Permanent Mol...
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471163245·Comfort Hook™ First Molar Weldable Convertible ...
QUARTZ FIBER CATHETERS AND SURGICAL TIPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
FDA 510(k)
FDA Class 2
·Immunology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·June 27, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·January 7, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 16, 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