8 results · 18ms · Sources: EU EUDAMED, US FDA

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DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)

FDA 510(k)
FDA Class 2 ·Hematology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450286586·

REPROCESSED RF ARTHROSCOPY PROBES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ON-Q PAIN PUMP

FDA Adverse Event
Injury ·I-FLOW, LLC·Product code MEB·January 8, 2013

NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

FDA Adverse Event
Injury ·HOLOGIC·Product code MNB·November 24, 2010

HYDRA JAGWIRE?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·July 3, 2014

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