20 results · 23ms · Sources: EU EUDAMED, US FDA

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BAERVELT PARS PLANA GLAUCOMA IMPLANT

FDA 510(k)
FDA Class 2 ·Ophthalmic

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

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

GENERAL ANESTHESIA SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

ARTHREX ATRAUMATIC MINI-GRASPER

FDA 510(k)
FDA Class 2 ·Orthopedic

PATHROMTIN SL

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

PATHROMTIN SL

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·August 11, 2017

ATTAIN ABILITY PLUS

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

PRECISION XTRA

FDA Adverse Event
Malfunction ·Product code NBW·January 10, 2011

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code OSI·July 24, 2014

PATHROMTIN SL (RILIBAK)

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GFO·January 4, 2023

VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

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