10 results · 22ms · Sources: EU EUDAMED, US FDA

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GALT MEDICAL GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

OTODYNAMICS, LTD.

FDA registration
OTODYNAMICS, LTD.·2 products·🇬🇧 United Kingdom

COLLATEK POWDER

FDA 510(k)
FDA Unclassified ·Unknown

DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 26, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 8, 2011

HEMODIALYSIS KIT: 2-L 15 FR X 32CM

FDA Adverse Event
Injury ·ARROW INTL., INC.·Product code MSD·March 31, 2008

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 Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014