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

HSX 2021-01-08

ACS LD Uni FB Knee System

Applicant Implantcast GmbH

K-Number K203341

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FRC 2021-01-08

Celerity 20 Steam Biological Indicator for IUSS

Applicant STERIS Corporation

K-Number K202721

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MBI 2021-01-08

Button Loop

Applicant Yunyi (Beijing) Medical Device Co., Ltd.

K-Number K202291

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QAT 2021-01-08

i-STAT TBI Plasma cartridge with the i-STAT Alinity System

Applicant Abbott Laboratories

K-Number K201778

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NUC 2021-01-08

Passion Natural Water Based Lubricant

Applicant Xr, LLC

K-Number K202017

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KGN 2021-01-07

MatriDerm

Applicant Medskin Solutions Dr. Suwelack AG

K-Number K201577

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FMF 2021-01-07

Instylla Delivery Kit

Applicant Instylla, Inc.

K-Number K202544

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KPR 2021-01-07

MULTIX Impact

Applicant Siemens Medical Solutions USA, Inc.

K-Number K203345

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FTL 2021-01-07

SurgiWrap FROST

Applicant Mast Biosurgery

K-Number K200918

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MHX 2021-01-07

BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K202405

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ODP 2021-01-07

ZSFab Cervical Interbody System

Applicant Zsfab, Inc.

K-Number K202488

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LLZ 2021-01-07

BrainInsight

Applicant Hyperfine Research, Inc.

K-Number K202414

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