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

NUH 2019-08-16

GIM-STIM OTC TENS/EMS System

Applicant Gemore Technology Co, Ltd.

K-Number K190988

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BZC 2019-08-16

Vyntus BODY

Applicant Vyaire Medical, Inc.

K-Number K190853

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HQC 2019-08-16

COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal

Applicant Johnson & Johnson Surgical Vision, Inc.

K-Number K191933

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NFW 2019-08-16

SAFECARE® THC Urine Strip Test

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K191924

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JDR 2019-08-16

TriMAX Implant System

Applicant Crossroads Extemity Systems, LLC

K-Number K190722

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KGO 2019-08-16

Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

Applicant Hartalega NGC Sdn. Bhd.

K-Number K183536

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JAA 2019-08-16

PowerDR

Applicant Radiology Information Systems, Inc.

K-Number K191504

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CFR 2019-08-16

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

Applicant Roche Diagnostics

K-Number K191899

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ODP 2019-08-16

Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device

Applicant Titan Spine, Inc.

K-Number K192018

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FAD 2019-08-16

Tria Soft Ureteral Stent

Applicant Boston Scientific Corporation

K-Number K191609

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BWF 2019-08-16

Combined Aerobika OPEP and VersaPAP device

Applicant Trudell Medical International

K-Number K183108

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ELC 2019-08-16

Piezon Built-in Kit, Piezon Built-in Kit LED

Applicant E.M.S Electro Medical Systems S.A

K-Number K191079

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