9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
T4 MONITOR STIMULATOR COMPUTER
FDA 510(k)
FDA Class 2
·Anesthesiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209121045·
ALLWOUND
FDA 510(k)
FDA Unclassified
·Unknown
KATANA AVENCIA Block
FDA 510(k)
FDA Class 2
·Dental
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·May 28, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 5, 2010
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·November 30, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024