Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GZI 2023-12-28

EvoWalk 1.0 System

Applicant Evolution Devices, Inc.

K-Number K230997

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ORZ 2023-12-27

TearCare MGX System

Applicant Sight Sciences, Inc.

K-Number K231084

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LON 2023-12-27

Colibrí

Applicant Copan Wasp Srl

K-Number K232756

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DQY 2023-12-27

TriSalus TriGuideTM Guiding Catheter

Applicant Trisalus Life Sciences

K-Number K233858

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PIW 2023-12-27

Nurochek-II System

Applicant Headsafe Mfg Pty, Ltd.

K-Number K231914

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ODG 2023-12-27

EndoSound Vision System; EVS

Applicant Endosound, Inc.

K-Number K232518

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QIH 2023-12-26

TumorSight Viz

Applicant SimBioSys, Inc.

K-Number K231130

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NQJ 2023-12-26

Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Applicant Nuwellis, Inc.

K-Number K233515

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IPF 2023-12-26

BTL-899M

Applicant BTL Industries, Inc.

K-Number K232937

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NKB 2023-12-26

POWEReam 1/4 Drive

Applicant Stryker Instruments

K-Number K233300

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MBI 2023-12-26

Suture Wing

Applicant Osteonic Co., Ltd.

K-Number K233659

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JKA 2023-12-22

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder

Applicant Jiangsu Kangbao Medical Equipment Co., Ltd.

K-Number K232881

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