10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994806048·TRIAL 2981322 CAPSTONE 13 X 22MM
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981322·anteriors; shade C3; mould UM6
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM Sola
FDA 510(k)
FDA Class 2
·Radiology
ROD
FDA Adverse Event
Malfunction
·SYNTHES·Product code HSB·February 27, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 2, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2014
Colonoscope, Model Number CF-HQ190L.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
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