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

LLZ 2021-07-23

MySpine WebPlanner & MyBalance

Applicant Medacta International S.A.

K-Number K211386

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LZA 2021-07-22

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K211220

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FXX 2021-07-22

Single-use medical face mask

Applicant Zhuhai Herald Datanetics Limited.

K-Number K210391

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HWC 2021-07-22

Medline UNITE® Digital Fusion Screw System

Applicant Medline Industries, Inc.

K-Number K211944

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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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