10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ACU-SUTURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088101·Box Cutter, 9mm x 9mm
CISNAP CLOSED INCISION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POTENS +
FDA 510(k)
FDA Class 2
·Hematology
HEARTSTREAM FR2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 21, 2013
CROSSFIRE CONSOLE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·December 13, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
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