11 results
·
32ms
·
Sources: EU EUDAMED, US FDA
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
FDA 510(k)
FDA Class 1
·Ophthalmic
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AltiVate Anatomic Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
ELLIPSE DR ICD, US
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWS·September 18, 2024
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·September 18, 2024
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Injury
·COVIDIEN MFG DC BOULDER·Product code GEI·November 27, 2024
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code FTL·December 7, 2012
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSABL
FDA Adverse Event
HOLOGIC·Product code MKN·September 28, 2010
PERCEPT
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 15, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012