8 results · 25ms · Sources: EU EUDAMED, US FDA

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CONMED VCARE RETRACTOR/ELEVATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

DISTRACTION, INTERNAL

FDA UDI
KLS-Martin L.P.·00888118093950·SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM...

MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE

FDA 510(k)
FDA Class 2 ·Cardiovascular

STRETCH WRAP

FDA 510(k)
FDA Class 1 ·General Hospital

SYMBIQ DCHANNEL 3.01

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 12, 2014

SPRINT QUATTRO

FDA Adverse Event
Malfunction ·MPRI·Product code LWS·February 11, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·January 10, 2011

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