9 results
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19ms
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Sources: EU EUDAMED, US FDA
ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTO DII MULTI FREQUENCY
FDA 510(k)
FDA Class 2
·Radiology
ELECTRONIC CELL ENERGIZER
FDA 510(k)
FDA Class 2
·Physical Medicine
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 18, 2014
CAROTID WALLSTENT MONORAIL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIM·October 19, 2010
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·December 14, 2012
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·June 6, 2018
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024