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

FOZ 2020-12-18

BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

Applicant Becton, Dickinson and Company

K-Number K201075

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POK 2020-12-18

EchoGo Pro

Applicant Ultromics, Ltd.

K-Number K201555

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OKS 2020-12-18

LacriJet®

Applicant Fci (France Chirurgie Instrumentation) Sas

K-Number K201606

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GJS 2020-12-18

microINR System

Applicant Iline Microsystems, S.L.

K-Number K201185

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FLL 2020-12-18

Fever Garde

Applicant Hubdic Co., Ltd.

K-Number K191978

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FGE 2020-12-18

Advanix Biliary Stent with NaviFlex RX Delivery System

Applicant Boston Scientific Corporation

K-Number K203162

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IYE 2020-12-18

MOSAIQ Oncology Information System

Applicant Elekta Solutions AB

K-Number K203172

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GEI 2020-12-18

Aesculap Caiman 12 Seal and Cut Technology System

Applicant Aesculap, Inc.

K-Number K203461

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NHA 2020-12-18

Blue Sky Bio CAD-CAM Abutments

Applicant Blue Sky Bio, LLC

K-Number K202026

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OVE 2020-12-18

IdentiTi Cervical Standalone Interbody System

Applicant Alphatec Spine, Inc.

K-Number K202812

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NKG 2020-12-18

Invictus™ OCT Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K203125

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OLO 2020-12-18

ADAPT for Gamma3

Applicant Stryker GmbH

K-Number K202749

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