8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMSINO SUTURE REMOVAL KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECICE Intramedullary Limb Lengthening System
FDA 510(k)
FDA Class 2
·Orthopedic
HEALON D
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTICS·Product code LZP·December 3, 2008
VALLEYLAB SUCTION COAGULATOR 10FR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE·Product code GEI·September 2, 2011
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 26, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013