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

PBK 2018-09-21

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

Applicant Centers for Disease Control and Prevention

K-Number DEN070001

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OLO 2018-09-21

Spineology Navigation Instruments

Applicant Spineology, Inc.

K-Number K182345

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LLZ 2018-09-21

Volpara Imaging Software

Applicant Volpara Health Technologies Limited

K-Number K182310

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OLI 2018-09-21

Cellulize

Applicant Ward Photonics, LLC

K-Number K180338

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ONB 2018-09-21

TEVADAPTOR Closed Drug Reconstitution and Transfer System

Applicant Teva Medical Ltd., Migada Plant

K-Number K180489

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FEQ 2018-09-21

AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm

Applicant United States Endoscopy Group, Inc.

K-Number K182258

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MAX 2018-09-21

Tranquil-L Interbody System

Applicant Nexus Spine, LLC

K-Number K181702

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EZL 2018-09-21

PSM 3-Way Silicone Foley Catheter

Applicant Pathway, LLC

K-Number K181616

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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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