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

DSA 2018-09-20

Medline Patient Cables and Lead Wires

Applicant Medline Industries, Inc.

K-Number K181726

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DJC 2018-09-20

OralTox Oral fluid Drug Test

Applicant Premier Biotech, Inc.

K-Number K181305

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PBK 2018-09-20

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Applicant Centers for Disease Control and Prevention

K-Number K181205

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KWS 2018-09-20

Aequalis Flex Revive Shoulder System

Applicant Tornier, Inc.

K-Number K181420

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GEI 2018-09-20

NICO Myriad

Applicant Nico Corporation

K-Number K182340

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NDC 2018-09-20

EndoTool SubQ

Applicant Al Pacheco and Associates

K-Number K180366

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IYN 2018-09-20

LOGIQ P9; LOGIQ P7

Applicant GE Healthcare

K-Number K181783

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NKB 2018-09-20

Chiral Surgical Pedicle Screw System

Applicant Chiral Surgical

K-Number K181995

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LZO 2018-09-20

MicroPort Orthopedics Total Hip Systems MR Labeling

Applicant Microport Orthopedics Inc. (Mpo)

K-Number K173898

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NGX 2018-09-20

Katalyst Mark 1 Muscle Stimulation System Model 2

Applicant Katalyst, Inc.

K-Number K181199

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EZL 2018-09-19

Bard Vertus Foley Catheter

Applicant C.R. Bard, Inc.

K-Number K180781

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MQP 2018-09-19

T2 STRATOSPHERE™ Expandable Corpectomy System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K181328

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