10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Invictus
FDA UDI
ALPHATEC SPINE, INC.·00190376242101·Tap, Cervical, 5.0mm
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
World Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE
FDA Adverse Event
Malfunction
·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996
HEARTSTART MRX - EMG DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 25, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025