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

ODP 2017-05-23

Fortilink-C with TETRAfuse 3D Technology

Applicant Rti Surgical, Inc.

K-Number K163673

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LYY 2017-05-23

LATEX EXAMINATION GLOVE POWDER FREE

Applicant Careglove Global Sdn. Bhd.

K-Number K161833

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NKB 2017-05-22

Dymaxeon Spine System

Applicant Back 2 Basics Direct, LLC

K-Number K170989

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PQZ 2017-05-22

Strep B Carrot Broth One-Step

Applicant Hardy Diagnostics

K-Number K170586

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KPS 2017-05-22

Hybrid3D

Applicant Hermes Medical Solutions AB

K-Number K163394

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LZA 2017-05-22

Powder Free Nitrile Patient Examination Gloves, Blue

Applicant Hebei Titans Medical Supply Technology Group., Ltd.

K-Number K163553

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NHA 2017-05-22

OSSTEM Implant System - Abutment

Applicant Osstem Implant Co., Ltd.

K-Number K161689

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HWC 2017-05-22

SMV Scientific Cannulated Screws

Applicant Smv Scientific

K-Number K170021

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JWH 2017-05-22

Smith & Nephew VISIONAIRE Adaptive Guides

Applicant Smith & Nephew, Inc.

K-Number K170282

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ITX 2017-05-22

Pinpoint GT Needle Guide Kits

Applicant C.R. Bard, Inc.

K-Number K171348

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GEX 2017-05-22

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

Applicant Lumenis, Ltd.

K-Number K170121

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HEX 2017-05-21

LT-300 SD Digital Video Colposcope

Applicant Lutech Industries, Inc.

K-Number K170446

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