14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIO PLUG
FDA UDI
Biomet Orthopedics, LLC·00880304255142·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613123031·Non-Vented Duo Guards, Yellow, 4.8mm x 25.4mm, ...
Curaplex
FDA UDI
BOUND TREE MEDICAL, LLC·00817617020754·Curaplex PVC LMA, Size 2.5
Curaplex
FDA UDI
BOUND TREE MEDICAL, LLC·00817617025865·Curaplex PVC LMA, Size 2.5
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Echo-Screen Hearing Screening Supplies
FDA UDI
NATUS MEDICAL INCORPORATED·00382830051231·25 sets of Echo-Screen II Ear Couplers and 25 s...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 9, 2024
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 11, 2013
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code EZB·July 15, 2011
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
FDA Enforcement
Class II
·Ongoing·Quidel Corporation·May 1, 2024
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014