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

OAT 2019-02-05

Absoanchor Microimplant

Applicant Dentos, Inc.

K-Number K181142

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PGY 2019-02-05

JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K183498

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LZC 2019-02-05

Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Applicant O&M Halyard, Inc.

K-Number K183132

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MAX 2019-02-04

EIT Cellular Titanium Lumbar Cage - T/PLIF

Applicant Eit Emerging Implant Technologies GmbH

K-Number K183447

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LJO 2019-02-04

Capture-CMV

Applicant Immucor, Inc.

K-Number K183571

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PGY 2019-02-04

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K183499

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NDC 2019-02-04

d-Nav System

Applicant Hygieia, Inc.

K-Number K181916

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ODP 2019-02-04

Velofix Interbody Fusion System

Applicant U&I Corporation

K-Number K190067

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OMP 2019-02-01

Invia Abdominal Dressing Kit

Applicant Medela AG

K-Number K182191

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KCT 2019-02-01

Endoscope Sterilization Tray

Applicant Intuitive Surgical, Inc.

K-Number K183139

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KWQ 2019-02-01

SECULOK ACP System

Applicant U&I Corporation

K-Number K190053

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JAK 2019-02-01

Supria True64 Whole-Body X-Ray CT System

Applicant Hitachi Healthcare Americas

K-Number K183291

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