10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756375160·CATH LAB PACK
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112335·SURG-I-BAND LIME GREEN
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 2, 2014
ULTRACISION HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·February 4, 2008
SYRINGE 50ML LL AMBER
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 5, 2021
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024