9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
iQ-solutions
FDA 510(k)
FDA Class 2
·Radiology
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
FDA 510(k)
FDA Class 2
·Radiology
SURVEYOR CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
GOLD-TITE HEXED UNISCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·November 18, 2024
GOLD-TITE HEXED UNISCREW
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·November 18, 2024
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
PROTOCO2L INSUFFLATION SYSTEM
FDA Adverse Event
Injury
·E-Z-EM, INC.·Product code FCX·July 11, 2013
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015