FDA 510(k) Applications Submitted by Ariell Joiner
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K211344 |
05/03/2021 |
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems |
Medos International SARL |
K201686 |
06/22/2020 |
GYNECARE TVTÖ System, GYNECARE TVTÖ with Abdominal Guides System, GYNECARE TVTÖ Introducer and Catheter Guide, GYNECARE TVT EXACTÖ Continence System and Trocar, GYNECARE TVTÖ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVOÖ Continence |
Ethicon Inc. |
K182873 |
10/12/2018 |
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices |
Ethicon, Inc. |
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