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

KNS 2019-06-21

Aqua Medical RF Vapor System

Applicant Aqua Medical, Inc.

K-Number K183595

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NKB 2019-06-21

LineSider Spinal System

Applicant Integrity Implants, Inc.

K-Number K190360

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NUH 2019-06-21

JKH Stimulator Plus

Applicant Jkh USA, LLC

K-Number K191151

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OVD 2019-06-21

AXTi Titanium Stand-Alone ALIF System

Applicant Innovasis, Inc.

K-Number K182139

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OXO 2019-06-21

OrthoScan TAU Mini C-Arm

Applicant Orthoscan, Inc.

K-Number K183220

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NGX 2019-06-21

emFieldPro

Applicant Zimmer Medizinsysteme GmbH

K-Number K182963

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HKX 2019-06-21

MiiS Horus Scope DPT 100

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K181260

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MQL 2019-06-21

Vit Kit- Freeze NX and Vit Kit- Warm NX

Applicant Fujifilm Irvine Scientific, Inc.

K-Number K190152

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MWP 2019-06-20

Kubtec Mozart (Xpert42)

Applicant Kub Technologies, Inc.

K-Number K183624

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KTW 2019-06-20

PK High Tibial Osteotomy Correction System

Applicant Paonan Biotech Co., Ltd.

K-Number K182285

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LQP 2019-06-20

Campylobacter Quik Chek

Applicant Techlab, Inc.

K-Number K191456

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LZA 2019-06-20

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate

Applicant Gx Corporation Sdn Bhd

K-Number K183354

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