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

EBG 2024-05-23

dima Print Teeth & Temp

Applicant Kulzer, LLC

K-Number K233868

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MRN 2024-05-23

NOxBOXi Nitric Oxide Delivery System

Applicant Linde Gas & Equipment, Inc.

K-Number K233251

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OMP 2024-05-23

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)

Applicant Kci USA, Inc.

K-Number K241134

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QFM 2024-05-23

VinDr-Mammo

Applicant Vinbigdata Joint Stock Company

K-Number K233108

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GEI 2024-05-23

CWM-930S, FIXER DV9

Applicant Chungwoo Co., Ltd.

K-Number K233120

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FRA 2024-05-23

AirKEE T900

Applicant Healkee Medical Pte, Ltd.

K-Number K232642

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OWB 2024-05-22

Zenition 90

Applicant Philips Medical Systems Nederlands B.V.

K-Number K240224

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DZE 2024-05-22

Paltop Short Implants

Applicant Paltop Advanced Dental Solutions, Ltd.

K-Number K232740

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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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