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

DXN 2017-02-14

Fully Automatic Electronic Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K162668

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LZC 2017-02-13

POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs

Applicant Hebei Hongsen Plastics Technology Co, Ltd.

K-Number K163146

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FRO 2017-02-13

KerraCel Ag Gelling Fiber Silver Dressing

Applicant Exciton Technologies, Inc.

K-Number K162508

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PNO 2017-02-13

Serranator Alto PTA Serration Balloon Catheter

Applicant Cagent Vascular, LLC

K-Number K163380

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LIT 2017-02-13

Advance 14LP Low Profile PTA Balloon Dilatation Catheter

Applicant Cook Incorporated

K-Number K170193

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OCC 2017-02-13

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Applicant Cepheid

K-Number K162456

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LON 2017-02-13

VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)

Applicant bioMerieux, Inc.

K-Number K161510

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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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