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

GEI 2021-01-26

BTL-899ST

Applicant Btl

K-Number K202199

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NKB 2021-01-26

M.U.S.T. Pedicle Screw Extension and Long Tab Implants

Applicant Medacta International S.A.

K-Number K203482

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DQA 2021-01-25

Pulse Oximeter

Applicant Shenzhen Creative Industry Co., Ltd.

K-Number K201468

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IYN 2021-01-25

Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28

Applicant Edan Instruments, Inc.

K-Number K202856

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IYN 2021-01-25

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

Applicant Viasonix , Ltd.

K-Number K202742

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FMF 2021-01-25

BD Hypodermic Syringe

Applicant Becton, Dickinson and Company

K-Number K203453

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OAS 2021-01-25

vatech A9 (Model : PHT-30CSS)

Applicant VATECH Co., Ltd.

K-Number K203797

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FLL 2021-01-25

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

Applicant Uni-Trend Technology (China) Co., Ltd.

K-Number K203747

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MAX 2021-01-25

VERTACONNECT TLIF Cage

Applicant Signus Medizintechnik

K-Number K203327

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NPK 2021-01-23

Cytoplast Titanium-Reinforced PTFE Membranes

Applicant Osteogenics Biomedical, Inc.

K-Number K201187

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MHX 2021-01-23

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K202336

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DZE 2021-01-22

Simply Iconic Implants

Applicant Implant Direct Sybron Manufacturing, LLC

K-Number K201553

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