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

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CARIES FINDER

FDA 510(k)
FDA Class 2 ·Dental

ADSON-BECKMAN RETRACTOR, SPINAL

FDA 510(k)
FDA Class 2 ·Neurology

MAALEABLE FACIAL IMPLANT

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

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

PEDICLE SCREW LOCKING TOWER ENH 2019

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·April 11, 2024

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 5, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

BAERVELDT SHUNT

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code KYF·September 4, 2012

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Injury ·MPRI·Product code DTB·February 11, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

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

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 24, 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