28 results · 22ms · Sources: EU EUDAMED, US FDA

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CurvaFix IM System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376519685·12 mm CORE ENDPLATE, LAT 22 x 25 mm 5°

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376520674·16 mm CORE ENDPLATE, LAT 22 x 25 mm 5°

FlexiNylon cartridges Standard Pink

FDA UDI
PERFLEX LTD·07290110500535·box of 6 identical cartridges sealed in aluminu...

Cardiovascular Procedure Kit

FDA UDI
Terumo Cardiovascular Systems Corporation·00699753512986·

FlexiNylon cartridges Standard Pink

FDA UDI
PERFLEX LTD·07290110506476·5 identical cartridges sealed in a vacuum bag ;...

PliaFX Flo

FDA UDI
LIFENET HEALTH·00889858640886·PliaFX Flo Flowable Demineralized Fibers, 5cc

SINGLE USE PRELOADED SPHINCTEROTOME V

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,

FDA 510(k)
FDA Class 1 ·Dental

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·October 9, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 17, 2025

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376670447·12mm CORE, NANOTEC LAT 22 x 25 mm 5°

Ascend

FDA UDI
ALPHATEC SPINE, INC.·00190376658223·16mm CORE, NANOTEC LAT 22 x 25mm 5°

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·November 25, 2024

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·January 8, 2025

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·March 6, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 11, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·February 13, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025