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

JAA 2021-08-31

DR 800 with DSA, DR 800

Applicant Agfa N.V.

K-Number K212145

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MQV 2021-08-31

Tactoset Injectable Bone Substitute

Applicant Anika Therapeutics, Inc.

K-Number K212083

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OWB 2021-08-31

EndoNaut

Applicant Therenva Sas

K-Number K212383

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MWP 2021-08-31

Kubtec Mozart (XPERT42)

Applicant Kub Technologies, Inc.

K-Number K210956

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DQK 2021-08-31

Ablamap Software

Applicant Ablacon, Inc.

K-Number K203084

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ODP 2021-08-31

CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System

Applicant Orthofix, Inc.

K-Number K211704

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MWP 2021-08-31

Kubec Xpert 80 Radiography System

Applicant Kub Technologies, Inc.

K-Number K210957

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GXY 2021-08-31

Adhesive Electrode

Applicant Shaoxing Yingtuo Healthcare Co., Ltd.

K-Number K210448

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OUR 2021-08-31

Triton Sacroiliac Joint Fixation System

Applicant Choice Spine, LLC

K-Number K211449

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MYN 2021-08-31

Auto Lung Nodule Detection

Applicant Samsung Electronics Co., Ltd.

K-Number K201560

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FLL 2021-08-31

PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG

Applicant Jkh USA, LLC

K-Number K203636

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DXN 2021-08-30

Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681

Applicant Shenzhen Yuezhongxing Technology Co., Ltd.

K-Number K211041

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