Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

ODG 2024-03-08

Ultrasonic Gastrovideoscope

Applicant Sonoscape Medical Corp.

K-Number K231813

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MBI 2024-03-07

ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor

Applicant Stryker Endoscopy

K-Number K240407

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MQB 2024-03-07

0909FCC, 0909FCC-HS

Applicant Rayence Co., Ltd.

K-Number K240371

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IYN 2024-03-07

Voluson Signature 20, Voluson Signature 18

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K233692

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JKA 2024-03-07

Safety Sliding Blood Collection Set

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K232781

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MQV 2024-03-07

Synthetic Bone Putty

Applicant Ventris Medical

K-Number K240458

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PNO 2024-03-07

D·Kutting™ PTA Scoring Balloon Dilatation Catheter

Applicant Dk Medical Technology Co., Ltd.

K-Number K232207

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HGX 2024-03-06

Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K233880

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MAX 2024-03-06

“BioGend” Interbody Fusion System 001 Cage

Applicant Biogend Therapeutics Co., Ltd.

K-Number K233075

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FMF 2024-03-06

Insulin Syringe

Applicant Spm Medicare Pvt. , Ltd.

K-Number K233794

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IYO 2024-03-06

EdgeFlow UH10

Applicant Edgecare, Inc.

K-Number K231677

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HHW 2024-03-06

Gynethotics™ Pessary

Applicant Cosm Medical

K-Number K231786

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