10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
2.4MM SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036061586·2.7MM X 18MM HIGH TORQUE CROSS-DRIVE SCREW
A-FIT®
FDA UDI
Gc Orthodontics America Inc.·E53581271800001·A-FIT® 2. MOLAR UPR LFT SZ 18
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NUVASIVE NVM5 SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POSITIVE COMBO 33
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LRG·April 25, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 31, 2012
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 17, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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