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

PKC 2021-07-16

Ignite Stemless Anatomic Shoulder System

Applicant Ignite Orthopedics, LLC

K-Number K203108

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KLE 2021-07-16

PacBond One

Applicant Pac-Dent, Inc.

K-Number K210186

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GAM 2021-07-16

StitchKit

Applicant Origami Surgical Inc .

K-Number K211792

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PHL 2021-07-16

ExoAtlet-II

Applicant Exoatlet Asia Co. , Ltd.

K-Number K201473

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MQC 2021-07-16

JS Dental Lab Mouth Guard

Applicant Ampower Dental Laboratories, LLC

K-Number K210011

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KRA 2021-07-16

SwiftNINJA Steerable Microcatheter

Applicant Merit Medical Systems, Inc.

K-Number K211525

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FXX 2021-07-16

Velguard Surgical Face Mask

Applicant Esstee Exports Health Care Division

K-Number K210761

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GEI 2021-07-16

Soniquence Reusable Bipolar Cable

Applicant Soniquence, LLC

K-Number K211946

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HRS 2021-07-16

Avanti Orthopaedics Ulnar Shortening System

Applicant Avanti Orthopaedics, Inc.

K-Number K211592

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FPA 2021-07-16

Medtronic Extended infusion set

Applicant Unomedical A/S

K-Number K210544

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OVE 2021-07-16

SureMAX-SA Cervical Standalone System

Applicant Additive Implants, Inc.

K-Number K211111

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KXT 2021-07-16

ADVIA Centaur® Digoxin assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K193397

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