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

BZD 2017-09-28

AirFit N20

Applicant Resmed, Ltd.

K-Number K171212

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GAM 2017-09-28

MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K172659

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MQL 2017-09-28

Gems Oocyte Retrieval Buffer ORB-20, ORB-50

Applicant Genea Biomedx Pty, Ltd.

K-Number K170498

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LOD 2017-09-28

TRAUMACEM V+ Injectable Bone Cement

Applicant Synthes (USA) Products, LLC

K-Number K170802

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LFL 2017-09-28

CUSA Excel+ Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K172595

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NKB 2017-09-28

NuVasive® Precept Spinal System

Applicant Nu Vasive, Incorporated

K-Number K171894

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GEI 2017-09-28

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

Applicant Modern Medical Equipment Manufacturing Limited

K-Number K163442

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MAX 2017-09-28

NuVasive TLX Interbody System

Applicant Nu Vasive, Incorporated

K-Number K171633

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NHA 2017-09-28

Anatotemp Anatomic Dental Implant Healing Abutment

Applicant Buckeye Medical Technologies, LLC

K-Number K171922

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FAS 2017-09-28

Resection Electrodes with HF cable

Applicant Olympus Winter & Ibe GmbH

K-Number K171965

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DZE 2017-09-28

MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm

Applicant Sterngold Dental, LLC

K-Number K171728

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ORC 2017-09-28

SurgiCube

Applicant Surgicube International B.V.

K-Number K163455

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