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

HWC 2017-04-04

OsteoMed ExtremiFix Mid and Large Screw System

Applicant Osteomed, LLC

K-Number K163303

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HWC 2017-04-04

BePOD Cannulated Arthrodesis Screws

Applicant Fournitures Hospitalieres Industrie

K-Number K170040

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EBZ 2017-04-04

Bluephase Style 20i

Applicant Ivoclar Vivadent, AG

K-Number K163613

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PGY 2017-04-04

MX50N(MX50YQS)

Applicant Wide Corporation

K-Number K170781

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IYN 2017-04-04

Acuson SC2000 Diagnostic Ultrasound System

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K170315

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PLF 2017-04-03

TITAN 3-D Wedge System

Applicant Paragon 28

K-Number K162241

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DQX 2017-04-03

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

Applicant Asahi Intecc Co., Ltd.

K-Number K163426

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EBF 2017-04-03

ESTELITE BULK FILL Flow

Applicant Tokuyama Dental Corporation

K-Number K161353

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PQN 2017-04-03

AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)

Applicant Airxpanders, Inc.

K-Number K170075

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LZO 2017-03-31

AMIStem-H Proximal Coating

Applicant Medacta International S.A.

K-Number K161635

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NHA 2017-03-31

Multibase Abutments EV and ATLANTIS Suprastructures

Applicant Dentsply Sirona

K-Number K163350

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MAX 2017-03-31

LOSPA IS TLIF & DLIF Cages

Applicant Corentec Co., Ltd.

K-Number K170243

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