8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PHOSPHORUS REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
FDA 510(k)
FDA Class 2
·Orthopedic
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
FDA 510(k)
FDA Class 2
·Cardiovascular
FT BIPOLAR RESECTION CORD STORZ
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 1, 2014
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·November 16, 2007
3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANG
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·October 10, 2012
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
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024