9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Zuma
FDA UDI
Seaspine Orthopedics Corporation·10889981097486·Modular Bullet Paddle Distractor 17mm
HEAD & FOOT END DROP PEDI-CRIB
FDA 510(k)
FDA Class 2
·General Hospital
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INTER-LOCK SCREWDRIVE T25/3.5MM HEX/330MM
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·November 16, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 11, 2013
AIM INNER CATHETER
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DQY·January 10, 2011
CAPTIVATOR?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·July 24, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024