8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
Calibration Gas 2
FDA UDI
Radiometer Medical ApS·05700699621757·Calibration gas 2, 10bar on-board gas bottle fo...
CRYOCARE CN2 SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 3, 2015
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 14, 2013
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 17, 2011
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