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

MAX 2018-08-13

TirboLOX-L Lumbar IBFD

Applicant Captiva Spine, Inc.

K-Number K180990

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NKB 2018-08-13

Zenius, Iliad and Kora Spinal Fixation Systems

Applicant Medyssey USA, Inc.

K-Number K181978

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LNH 2018-08-13

Vantage Galan 3T, MRT-3020/A7, V5.0

Applicant Canon Medical Systems Corporation

K-Number K181593

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OZZ 2018-08-13

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K173498

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DXH 2018-08-11

CARDIOSKIN

Applicant Bioserenity Sas

K-Number K173248

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MRC 2018-08-10

Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner

Applicant Bausch & Lomb, Incorporated

K-Number K181627

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OVD 2018-08-10

CoreLink® M3 Stand-Alone Anterior Lumbar System

Applicant Corelink, LLC

K-Number K180814

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DPS 2018-08-10

physiQ Heart Rhythm Module

Applicant Physiq, Inc.

K-Number K180234

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PYT 2018-08-10

Natural Cycles

Applicant Natural Cycles Nordic AB

K-Number DEN170052

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LZC 2018-08-10

Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K-Number K181130

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EHD 2018-08-10

Portable X-ray System (Model: MiniX-V, Mini X-S)

Applicant Digimed Co., Ltd.

K-Number K181891

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ONB 2018-08-10

Diana Medication Transfer Set

Applicant Icu Medical, Inc.

K-Number K170110

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