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

KLE 2018-09-26

BeautiBond Universal

Applicant Shofu Dental Corporation

K-Number K180803

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FKP 2018-09-26

NxStage Connected Health System

Applicant Nxstage Medical, Inc.

K-Number K181991

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LCP 2018-09-25

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

Applicant Skyla Corporation H.S.P.B

K-Number K173127

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LCJ 2018-09-25

CPX 4 Breast Tissue Expander with Smooth Surface

Applicant Mentor Worldwide, LLC

K-Number K182335

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LLZ 2018-09-25

IBM iConnect Access

Applicant Merge Healthcare Incorporated

K-Number K182290

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IOR 2018-09-25

AST Model MA012 and MS019 Rehab Wheelchair

Applicant Sichuan Ast Medical Equipment Co., Ltd.

K-Number K181795

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BTC 2018-09-25

PeDIA

Applicant Pedia, LLC

K-Number K181424

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NKB 2018-09-25

OsseoScrew System

Applicant Alphatec Spine, Inc.

K-Number K181980

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LJS 2018-09-25

5 FR Dual Lumen Piper PICC

Applicant Piper Access, LLC

K-Number K181904

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LLZ 2018-09-25

Synapse 3D Optional Tools

Applicant Fujifilm Corporation

K-Number K181773

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NEU 2018-09-25

5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)

Applicant Health Beacons, Inc.

K-Number K181692

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PHX 2018-09-24

Comprehensive Reverse Shoulder System

Applicant Biomet Manufacturing Corp

K-Number K181611

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