10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STIMPEN
FDA 510(k)
FDA Class 2
·Anesthesiology
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268221390·General Surgical Kit
Stradis Healthcare
FDA UDI
STRADIS MEDICAL, LLC·M7526822139·General Surgical Kit
HIP TOOL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
SMITH & NEPHEW R3 CONSTRAINED LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTORNIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
SETROX S 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·June 5, 2015
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026