9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SUCTION SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981130220·Trial 16x14x6mm, 10 Deg Lordosis, w/ Depth Stop
CO-1000 COLPOSCOPE, MULTIPLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
FDA 510(k)
FDA Class 1
·Microbiology
VIRTUOSO
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
TI CLAMP FOR USS ILIAC
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HBL·October 4, 2010
MA204
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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