15 results
·
36ms
·
Sources: EU EUDAMED, US FDA
CHEMISTRY, COULTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021
4-WAY STOPCOCK W/7CM TUBING,
FDA 510(k)
FDA Class 2
·General Hospital
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
ACCU-CHEK INFORM EU PLASMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·October 29, 2007
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 3, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 24, 2014
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025
3.5MM TI LCP SUP ANT CLAVICLE PL W/LAT EXTN 7H/RT/123MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 21, 2019
CD HORIZON® SOLERA® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025
TSRH® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022