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

LNH 2021-07-22

QSM software, QSMetric

Applicant Medimagemetric, LLC

K-Number K210415

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JAK 2021-07-22

syngo.CT Skull Unfolding

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203411

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FYA 2021-07-22

Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K-Number K210143

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LZO 2021-07-22

POLARSTEM Cemented Femoral Stem

Applicant Smith & Nephew, Inc.

K-Number K203175

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FGB 2021-07-22

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

Applicant OTU Medical, Inc.

K-Number K210579

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CAC 2021-07-22

FlowSaver Blood Filter

Applicant Inari Medical

K-Number K210176

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LNH 2021-07-22

Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K211633

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PHX 2021-07-22

DELTA XTEND Reverse Shoulder System

Applicant Depuy Ireland UC

K-Number K203694

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FLL 2021-07-22

Temp Pal

Applicant Iweecare Co., Ltd.

K-Number K202603

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IYE 2021-07-22

ExacTrac Dynamic

Applicant Brainlab AG

K-Number K211939

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GCJ 2021-07-22

Arthrex SynergyID Endoscopic Imaging System

Applicant Arthrex, Inc.

K-Number K202582

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FMI 2021-07-22

NIO+ Adult

Applicant Waismed, Ltd.

K-Number K211968

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