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

MEG 2018-08-09

Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use

Applicant Berpu Medical Technology Co., Ltd.

K-Number K180417

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MBI 2018-08-09

ICONN Answer II Suture Anchor

Applicant Iconn Orthopedics, LLC

K-Number K181680

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GZL 2018-08-09

Anchor Bolt (as an accessory to Depth Electrodes)

Applicant Ad-Tech Medical Instrument Corporation

K-Number K181544

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FRO 2018-08-09

Titan Ag 200

Applicant Specialty Fibres and Materials, Ltd.

K-Number K173844

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NBW 2018-08-09

FORA GTel Blood Glucose Monitoring System

Applicant Foracare, Inc.

K-Number K173505

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JDR 2018-08-09

MotoCLIP/HiMAX Step Staple Implant System

Applicant Crossroads Extremity Systems, LLC

K-Number K181866

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NKB 2018-08-09

Kodiak Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K181677

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BZD 2018-08-08

F&P SleepStyle

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K173193

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FLL 2018-08-08

Ageless Health Medical Digital Thermometer

Applicant Ageless Health Industrial Co., Ltd.

K-Number K172508

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DQY 2018-08-08

EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length

Applicant Imperative Care, Inc.

K-Number K180169

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DZE 2018-08-08

UNIQA Dental Implants System

Applicant Uniqa Dental, Ltd.

K-Number K180598

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MWI 2018-08-08

SmartLinx Vitals Plus Patient Monitoring System

Applicant Capsule Technologie

K-Number K180734

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