17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
REMEL
FDA UDI
REMEL, INC.·00848838023088·Nitrocefin Disk 25Disk/VL
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSD·October 12, 2023
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014
SCREWDRIVER BLADE, T7, AO
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·August 6, 2011
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026
NC QUANTUM APEX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025