11 results
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18ms
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Sources: EU EUDAMED, US FDA
HDL CHOLESTEROL PRETREATMENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111503·KIT, IFAK - CUSTOM
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106280·HOFFER-MCPHERSON FORCEPS 1X2 TEETH
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197022750·Suction Tube
350mm,...
Endo-Model SL Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575384082·Modular Stem, with male taper for 6mm noses, ce...
Regular and Special Umbilical Cord Clamp and Cutter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
da Vinci SP Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 5, 2014
APOGEE
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 27, 2012
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 29, 2010
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024