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

JOW 2021-09-21

Dayspring Lite

Applicant Koya Medical, Inc.

K-Number K212287

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HIR 2021-09-21

Flyte

Applicant Pelvital USA, Inc.

K-Number K212655

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JAA 2021-09-21

ProxiDiagnost N90

Applicant Philips Medical Systems Dmc GmbH

K-Number K212837

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NKB 2021-09-21

Mariner Pedicle Screw System

Applicant SeaSpine Orthopedics Corporation

K-Number K212692

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MAX 2021-09-21

KEYSTONE PEEK Cage System

Applicant Shanghai Sanyou Medical Co, Ltd.

K-Number K211689

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OAS 2021-09-21

T2

Applicant Osstem Implant Co., Ltd.

K-Number K212303

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CIX 2021-09-21

Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

Applicant Medicon Hellas S.A

K-Number K200898

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HRS 2021-09-21

GEO Extremity and Ankle Plating System

Applicant Gramercy Extremity Orthopedics, LLC

K-Number K212334

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MMI 2021-09-21

Elecsys Troponin T Gen 5

Applicant Roche Diagnostics

K-Number K201441

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QPN 2021-09-21

Paige Prostate

Applicant Paige.Ai

K-Number DEN200080

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NXC 2021-09-20

SMILERS

Applicant Biotech Dental Smilers, Sas

K-Number K212961

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LYY 2021-09-20

Latex Examination Powder Free Gloves

Applicant Aspen Glove Sdn. Bhd.

K-Number K211477

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