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

IRP 2019-09-19

ProPerformance Recovery System

Applicant Menlo Brands, LLC

K-Number K192252

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INI 2019-09-19

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

Applicant Eurogreen International, Inc.

K-Number K182631

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JTN 2019-09-19

HardyDisk AST Lefamulin 20µg (LMU20)

Applicant Hardy Diagnostics

K-Number K192326

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KGI 2019-09-19

GEHC DXA Bone Densitometers with enCORE version 18

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K191112

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PML 2019-09-19

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

Applicant CarboFix Orthopedics , Ltd.

K-Number K190526

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IYN 2019-09-19

RS80 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K192030

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MQL 2019-09-18

GM501 Mineral Oil

Applicant Hamilton Thorne, Inc.

K-Number K191552

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MAX 2019-09-18

HEDRON Lumbar Spacers

Applicant Globus Medical, Inc.

K-Number K191391

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IPF 2019-09-18

geko T-2 and geko T-3 Neuromuscular Stimulators

Applicant Firstkind Limited

K-Number K191113

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CAP 2019-09-18

VORTRAN APM-Plus

Applicant Vortran Medical Technology 1, Inc.

K-Number K182292

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FAJ 2019-09-18

Flexible HD Cysto-Urethroscope System

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K191357

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PFO 2019-09-18

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

Applicant Med-El Elektromedizinische Geraete GmbH

K-Number K191457

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