9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IVFLO-HP & IVFIL-HP
FDA 510(k)
FDA Class 2
·General Hospital
CAPNOSTREAM20P WITH HIFI C02 MONITORING
FDA 510(k)
FDA Class 2
·Anesthesiology
CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FT BIPOLAR RESECTION CORD STORZ
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 1, 2014
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 16, 2007
BIPOLAR CUTTING LOOP ELECTRODE - DEVICE #2
FDA Adverse Event
Malfunction
·RICHARD WOLF MEDICAL INSTRUMENTS.·Product code KNS·September 3, 2010
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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015