8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PULSED AND CONTINUOUS SHORTWAVE APPAR.
FDA 510(k)
FDA Class 2
·Physical Medicine
Sklar®
FDA UDI
SKLAR CORPORATION·10649111189166·JACKSON TUBE ORIG SHORT #6 STL
ABSORPTION SPECTROPHOTOMETERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POGO Automatic Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCOLADE STEM INSERTER
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·April 30, 2014
PINN SECTOR W/GRIPTION 50MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·October 10, 2012
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 28, 2010
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
FDA Enforcement
Class II
·Ongoing·ev3 Inc·January 22, 2025