Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

ODP 2018-07-09

Curiteva Cervical Interbody Fusion System

Applicant Curiteva, LLC

K-Number K181261

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NPL 2018-07-09

Straumann Jason Membrane

Applicant Institut Straumann AG

K-Number K173562

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NUH 2018-07-08

BMLS16-1

Applicant Biomedical Life Systems, Inc.

K-Number K172971

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LZC 2018-07-08

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs

Applicant Shen Wei USA, Inc.

K-Number K173766

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DXT 2018-07-06

Sterile Disposable Syringes

Applicant Shenyang Mastech Medical Device Co., Ltd.

K-Number K172694

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HSX 2018-07-06

Materialise PKA Guide System

Applicant Materialise NV

K-Number K173970

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ODP 2018-07-06

Tyber Medical PT Interbody Spacer System

Applicant Tyber Medical, LLC

K-Number K180590

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KXK 2018-07-06

GammaTile

Applicant Isoray Medical, Inc.

K-Number K180515

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PWJ 2018-07-06

GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar

Applicant ETHICON, Inc.

K-Number K173019

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PRI 2018-07-06

Elecsys BRAHMS PCT

Applicant Roche Diagnostics

K-Number K173927

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DIO 2018-07-06

DRI Cocaine Metabolite Assay

Applicant Microgenics Corporation

K-Number K181499

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JSO 2018-07-06

CHROMID CARBA agar (CARB)

Applicant Biomerieux S.A.

K-Number K181092

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