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

OXO 2018-11-16

OEC One

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K182626

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NKB 2018-11-15

PathLoc-L MIS Spinal System

Applicant L&K BIOMED Co., Ltd.

K-Number K183117

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IYN 2018-11-15

Voluson E6, Voluson E8, Voluson E10

Applicant GE Healthcare

K-Number K181985

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DPS 2018-11-15

CardioBand ECG Event Recorder

Applicant Samsung Strategy and Innovation Center (Ssic)

K-Number K181998

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FTM 2018-11-15

CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)

Applicant Aziyo Biologics, Inc.

K-Number K182255

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QDS 2018-11-15

FilmArray Pneumonia Panel plus

Applicant Biofire Diagnostics, LLC

K-Number K181324

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EOX 2018-11-15

PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor

Applicant Cogentix Medical, Inc.

K-Number K181292

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LZA 2018-11-15

Nitrile Glove Powder Free Black

Applicant Haining Medical Products Co., Ltd.

K-Number K182528

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EBF 2018-11-15

Nexcomp

Applicant Meta Biomed Co., Ltd.

K-Number K181689

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MHX 2018-11-15

IntelliVue Multi-Measurement Module MMX

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K181831

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NKG 2018-11-15

YUKON OCT Spinal System

Applicant K2m

K-Number K182182

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EIH 2018-11-15

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent

Applicant Yeti Dentalprodukte GmbH

K-Number K173971

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