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

MBI 2019-09-12

MectaLock Ti Suture Anchor

Applicant Medacta International S.A.

K-Number K191300

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FXX 2019-09-11

3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask

Applicant 3M Healthcare

K-Number K191355

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PIW 2019-09-11

BrainScope TBI

Applicant Brainscope Company, Inc.

K-Number K190815

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MWI 2019-09-11

PeraMobile and PeraWatch

Applicant Perahealth, Inc.

K-Number K183370

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DXN 2019-09-11

CNAP Monitor

Applicant Cnsystems Medizintechnik GmbH

K-Number K183521

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EBG 2019-09-11

TurboTemp EZ

Applicant Zest Anchors, LLC

K-Number K191619

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PLV 2019-09-11

Neocis Guidance System (NGS)

Applicant Neocis, Inc.

K-Number K191605

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KWT 2019-09-11

Catalyst OrthoScience CSR Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K191811

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OMB 2019-09-11

Ceribell Pocket EEG Device

Applicant Ceribell, Inc.

K-Number K191301

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JAK 2019-09-10

AI-Rad Companion (Cardiovascular)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183268

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BZG 2019-09-10

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

Applicant Welch Allyn, Inc.

K-Number K191013

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HKI 2019-09-10

KOWA nonmyd 8

Applicant Kowa Company , Ltd.

K-Number K191945

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