8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODEL ELI 300 ELECTROCARDIOGRAPH
FDA 510(k)SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088163·Box Cutter, 9mm x 15mm
REXILLIUM III
FDA 510(k)
FDA Class 2
·Dental
PiXel8-Reveal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADVANCE CAPSULE DELIVERY DEVICE
FDA Adverse Event
UNITED STATES ENDOSCOPY GROUP, INC.·Product code KOG·January 11, 2013
POSEY STAYSAFE BED
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code FNL·December 13, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEATHCARE CORPORATION·Product code FKX·July 14, 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