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

DQX 2020-01-15

Wattson Temporary Pacing Guidewire

Applicant Vascular Solutions

K-Number K192454

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DGC 2020-01-15

ADVIA Centaur Total IgE (tIgE)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K193493

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OMP 2020-01-15

UNO 30

Applicant Genadyne Biotechnologies

K-Number K190028

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KPR 2020-01-15

KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography

Applicant Konica Minolta Healthcare Americas, Inc.

K-Number K193225

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EIH 2020-01-15

Livento Press, Soprano 10, Soprano

Applicant Cendres+Metaux SA

K-Number K192251

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LIT 2020-01-15

All’InCath 035M PTA Balloon Dilatation Catheter

Applicant Nexstep Medical

K-Number K191275

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HKY 2020-01-14

Icare ic200

Applicant Icare Finland OY

K-Number K190316

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GEX 2020-01-14

XTRAC Momentum Excimer Laser System

Applicant Strata Skin Sciences, Inc.

K-Number K193478

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NKB 2020-01-14

Streamline TL Spinal Fixation System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K192800

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OYJ 2020-01-14

Oragene®•Dx

Applicant DNA Genotek, Inc.

K-Number K192920

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PUB 2020-01-14

G210 InviCell Plus with SignipHy pH monitoring

Applicant CooperSurgical, Inc.

K-Number K191020

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MAX 2020-01-14

SABLE Expandable Spacer

Applicant Globus Medical, Inc.

K-Number K192115

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