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

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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FLL 2018-09-24

Probe Covers for Thermometers

Applicant K-Jump Health Co., Ltd.

K-Number K180714

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IZL 2018-09-24

AMADEO M-DR mini, AMADEO M-AX mini

Applicant Oehm Und Rehbein GmbH

K-Number K182317

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LLZ 2018-09-24

iNtuition-T1 Mapping and T2/T2* Mapping

Applicant Terarecon,Inc.

K-Number K180916

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LPH 2018-09-24

REDAPT Porous Acetabular Shell

Applicant Smith & Nephew, Inc.

K-Number K181366

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FAD 2018-09-21

Malecot Nephrostomy Catheter/Stent Set

Applicant Cook Incorporated

K-Number K180029

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