8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SAM JUNCTIONAL TOURNIQUET
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032478·Gown, L2 LG, 24-Pack NS
TISSUE SAMPLING NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 22, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 26, 2014
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 14, 2011
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