11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACA URINARY PROTEIN ANALYTICAL TEST PACK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222310·Cervical Rasp 5x12x12
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18222311·
Stradis Healthcare
FDA UDI
STRADIS MEDICAL, LLC·M7526822231·General Surgical Kit
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MECTALIF (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MAX·April 29, 2020
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 7, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 5, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015