11 results · 21ms · Sources: EU EUDAMED, US FDA

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MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS

FDA 510(k)
FDA Class 2 ·Neurology

REVELATION DIAMOND

FDA UDI
Ss White Burs, Inc.·D6909126852·REVELATION DIAMOND 852-012F - 5 PACK

Gen. Acces/ Instr. Tip Guard

FDA UDI
KATENA PRODUCTS, INC.·00841668110904·TIP GUARDS VENTED ORANGE PACK OF 100

KONICAMINOLTA DI-X1

FDA 510(k)
FDA Class 2 ·Radiology

REPROCESSED ENDOSCOPIC ELECTRODES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SYNFIX® EVOLUTION AWL/WITHOUT SLEEVE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HWJ·September 16, 2016

TECNIS MULTIFOCAL

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·December 2, 2010

ON-Q PAIN PUMP

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

PINNACLE MTL INS NEUT36IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 3, 2014

SEE H10

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018

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