11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
FDA 510(k)
FDA Class 2
·Orthopedic
V-Strap Wrist Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357232529·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
BD PARADIGM LINK BLOOD GLUCOSE MONITOR
FDA Adverse Event
Other
·BECTON DICKINSON·Product code NBW·July 29, 2005
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Multi-unit Abutments for CONELOG
FDA 510(k)
FDA Class 2
·Dental
SGL TRIG PIN COLLET 3.0-4.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 16, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 4, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KPE·July 12, 2013
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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025