9 results
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23ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE THORACIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135870·Boxcar Plate - Ø1.9 mm - 4 hole - 11 x 11 mm (1...
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
FDA 510(k)
FDA Class 2
·Dental
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
FDA 510(k)
FDA Class 2
·General Hospital
ACROBAT-I STABILIZER
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·March 26, 2014
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 2, 2015
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
FDA Enforcement
Class II
·Terminated·Terumo Cardiovascular Systems Corporation·July 30, 2014
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