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

HRX 2017-03-16

JOINIX CANNULAR SYSTEM

Applicant Aju Pharm Co., Ltd.

K-Number K162070

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PDQ 2017-03-16

NuVasive Next Generation NVM5 System

Applicant Nu Vasive, Incorporated

K-Number K162313

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JWH 2017-03-16

U2 Total Knee System E-XPE products

Applicant United Orthopedic Corporation

K-Number K161705

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LZO 2017-03-16

LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

Applicant Waldemar Link GmbH & Co. KG

K-Number K161840

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GWG 2017-03-16

TIPCAM 1S 3D System

Applicant Karl Storz Endoscopy America, Inc.

K-Number K162880

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LLZ 2017-03-16

FDX Console (DR-ID300CL) Software

Applicant Fujifilm Medical Systems U.S.A, Inc.

K-Number K170451

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NHA 2017-03-16

Multi-unit Abutment Plus

Applicant Nobel Biocare AB

K-Number K161416

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GGN 2017-03-16

VALIDATE Heparin Calibration Verification/Linearity Test Kit

Applicant Maine Standards Company, LLC

K-Number K163498

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INI 2017-03-16

KYMCO EQ10D Scooter

Applicant Kwang Yang Motor Co., Ltd.

K-Number K163201

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OVD 2017-03-16

MectaLIF Anterior Stand Alone

Applicant Medacta International S.A.

K-Number K170455

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MRG 2017-03-16

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

Applicant Siemens Healthcare Diagnostics

K-Number K162298

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MAX 2017-03-16

NuVasive Modulus XLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K163230

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