418 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
FDA 510(k)
FDA Class 2
·Cardiovascular
Neodent
FDA UDI
JJGC Indústria e Comércio de Materiais Dentários S/A.·07899878046943·NGS REGULAR INITIAL DRILL
Non-Adhesive Wrap
FDA UDI
SenTec AG·07640121881039·Sentec’s Non-Adhesive Wrap is intended to be wr...
RPMI-1640 MEDIUM, CATALOG NO. 210-3520
FDA 510(k)
FDA Class 1
·Hematology
Monster® Screw System
FDA UDI
Paragon 28, Inc.·00889795048950·P28, Drill, 3.5 x 200 mm, Cannulated, 3/16 Sq, SS
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657022033·5.5mm Blunt Obturator, 20cm Length
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386026383·Screw, Ø 3.5mm, length 20mm, high angulation
Sochi
FDA UDI
Altus Spine, LLC·00843210166261·Standard Screw, 3.5mm x 20mm
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052157·3.5mm x 20mm Standard Screw
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXAN SYSTEM, MODEL NX-300
FDA 510(k)
FDA Class 2
·Cardiovascular
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657021975·5.5mm Sharp/Pyramidal Trocar, 20cm Length
EPOC READER
FDA Adverse Event
Malfunction
·EPOCAL INC.·Product code CGL·April 12, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 9, 2013
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025