13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605548·MAQUET 1130 ORTHOPEDIC 4.25" DELUXE GEL
LOCATOR
FDA UDI
Zest Anchors, LLC·00840481101274·LOCATOR Bar Male Processing Package (2 Pack)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450600726·
NA
FDA UDI
STRYKER CORPORATION·07613327052688·Insert, Maryland Dissector
JAS AMYLASE LIQUID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 26, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 31, 2011
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·July 22, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014