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

OAB 2024-05-22

INUMI Flex Needle

Applicant Galvanize Therapeutics, Inc.

K-Number K233884

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FTM 2024-05-22

OviTex PRS

Applicant TELA Bio, Inc.

K-Number K241126

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QHE 2024-05-22

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K241143

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NGL 2024-05-22

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

Applicant Co-Innovation Biotech Co., Ltd.

K-Number K241100

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OHT 2024-05-22

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

Applicant Shenzhen Mlay Intelligent Technology Co., , Ltd.

K-Number K241106

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DXE 2024-05-22

Fogarty Venous Thrombectomy Catheters

Applicant Edwards Lifesciences, LLC

K-Number K233819

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GEI 2024-05-22

Gladiator

Applicant Rohrer Aesthetics, LLC

K-Number K233099

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OWB 2024-05-22

IntraOp Alignment System

Applicant Alphatec Spine, Inc.

K-Number K240199

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OAP 2024-05-22

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

Applicant Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC

K-Number K240456

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FRO 2024-05-22

Bonvadis®

Applicant Stemcyte, Inc.

K-Number K232655

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DQO 2024-05-22

Impress Angiographic Catheter

Applicant Merit Medical Systems, Inc.

K-Number K233268

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HTY 2024-05-22

Biomet Kirschner Wires (K-Wires)

Applicant Biomet, Inc.

K-Number K241014

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