8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Adaptix Ortho350
FDA 510(k)
FDA Class 2
·Radiology
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 30, 2024
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014
FREEDOM RINGLOC CONSTRAINED LINER 36MM STANDARD FACE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWZ·September 16, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·July 25, 2013
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024