13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEST FOR KETONE IN URINE(ACETOACETIC AC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Precept
FDA UDI
Nuvasive, Inc.·00887517351630·PRECEPT K-Wire, Threaded Blunt
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117743·Maumenee Colibri Forceps, .12mm, 1x2
Codman
FDA UDI
SYNERGETICS USA, INC.·20886704065446·Disposable Spetzler™-Malis® Standard Bipolar Fo...
SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
FDA 510(k)
FDA Class 2
·General Hospital
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FORTIFY ASSURA DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 23, 2012
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 11, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026