14 results
·
24ms
·
Sources: EU EUDAMED, US FDA
SAS SALMONELLA H,M,T, ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
BASE
FDA UDI
Nuvasive, Inc.·00887517701732·BASE Ti Bolt, 5.0x20.0mm Fixed
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128793·Revision Fluted Stem 20mm x 100mm
TPN FLUID TRANSFER SET
FDA 510(k)
FDA Class 2
·General Hospital
BARD PARKER PERFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·February 11, 2013
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. SHANGHAI·Product code INI·July 24, 2014
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 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