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

JAQ 2017-02-13

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

Applicant Kobold, LLC

K-Number K160610

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EBI 2017-02-13

JUVORA Dental Disc, Ceramill PEEK by JUVORA

Applicant Juvora

K-Number K160918

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JDW 2017-02-13

Ultima HA Coated Half Pins and Wire

Applicant Vilex IN Tennessee, Inc.

K-Number K163487

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MQV 2017-02-13

MCS Bone Graft

Applicant Bioventus, LLC

K-Number K162860

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GAM 2017-02-10

CRYLREX

Applicant Sm Eng Co., Ltd.

K-Number K161629

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EBW 2017-02-10

XSmart iQ

Applicant Dentsply Sirona

K-Number K161213

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DXN 2017-02-10

Blood Pressure Monitor

Applicant Beijing Choice Electronic Technology Co., Ltd.

K-Number K162089

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DTR 2017-02-10

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)

Applicant Medtronic, Inc.

K-Number K162774

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IYN 2017-02-10

LOGIQ P9 and LOGIQ P7

Applicant GE Healthcare

K-Number K163596

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LZO 2017-02-10

Revision Femoral Stem

Applicant Lima Corporate S.P.A.

K-Number K161226

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FMF 2017-02-10

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

Applicant Terumo Europe N.V.

K-Number K161606

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FRG 2017-02-10

SteriTite Containers System & MediTray Products

Applicant Case Medical, Inc.

K-Number K161415

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