9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ZINETICS INTERNAL REFERENCE PROBE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756372299·PAIN TRAY
CONCORDE BULLET SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INCLUDER CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
FDA Adverse Event
Malfunction
·Product code LJE·December 19, 2023
PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 30, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 2, 2014
KANGAROO EPUMP - INTERNATIONAL
FDA Adverse Event
Malfunction
·COVIDIEN·Product code JOW·December 4, 2012
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024