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

DHB 2019-03-19

AP3600 Automated Instrument

Applicant Hitachi Chemical Diagnostics, Inc.

K-Number K182793

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CBK 2019-03-19

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

Applicant Maquet Critical Care AB

K-Number K180098

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LLZ 2019-03-19

SIS Software version 3.3.0

Applicant Surgical Information Sciences, Inc.

K-Number K183019

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OMC 2019-03-19

AE-120A EEG Head Set

Applicant Nihon Kohden Corporation

K-Number K183529

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LZC 2019-03-19

Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K182383

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NKB 2019-03-18

Zavation Spinal System

Applicant Zavation Medical Products, LLC

K-Number K190361

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ISD 2019-03-18

REAL Immersive System

Applicant Penumbra, Inc.

K-Number K183296

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NHA 2019-03-18

Preat Abutments

Applicant Preat Corporation

K-Number K183518

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OHT 2019-03-18

Sensilight Pro / Pistol IPL

Applicant El Global Trade, Ltd.

K-Number K183260

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MBI 2019-03-18

Paradigm All-Suture Anchor 1.8mm, White/Black #2

Applicant Conmed Corporation

K-Number K190333

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OHT 2019-03-18

BRAUN Silk Expert Pro 3

Applicant Cyden Limited

K-Number K190366

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OZE 2019-03-18

ID NOW Influenza A & B 2

Applicant Alere Scarborough, Inc.

K-Number K190204

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