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

EBF 2019-07-03

Novidia Flowable Composite

Applicant Nobio , Ltd.

K-Number K182580

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NQW 2019-07-03

NuVasive® Camber Laminoplasty System

Applicant Nu Vasive, Incorporated

K-Number K191169

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MAX 2019-07-03

ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K190959

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MBI 2019-07-03

OsteoFab Suture Anchors

Applicant Oxford Performance Materials, Inc.

K-Number K190915

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DXN 2019-07-03

Arm-type Electronic Blood Pressure Monitor

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K183058

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EBF 2019-07-03

XP Composite

Applicant S&C Polymer Silicon- Und Composite Spezialitaeten GmbH

K-Number K182780

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PFO 2019-07-03

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

Applicant Cochlear Americas

K-Number K190589

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POK 2019-07-03

Koios DS for Breast

Applicant Koios Medical, Inc.

K-Number K190442

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EBG 2019-07-03

MD-Temp Plus

Applicant Meta Biomed Co., Ltd.

K-Number K190724

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IZH 2019-07-03

Biopsy Positioner

Applicant Fujifilm Corporation

K-Number K191495

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NLF 2019-07-03

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K191018

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EBZ 2019-07-03

Bluephase PowerCure

Applicant Ivoclar Vivadent, AG

K-Number K190272

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