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

PCC 2022-12-13

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

Applicant Cefaly Technology

K-Number K212071

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HWC 2022-12-13

REDEMPTION Beaming System

Applicant Vilex, LLC

K-Number K221342

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QAV 2022-12-13

HVT 2.0

Applicant Vapotherm, Inc.

K-Number K221318

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QFR 2022-12-13

Quantra QPlus System

Applicant Hemosonics, LLC

K-Number K223433

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GEX 2022-12-13

Epilaser Absolute

Applicant Epilady 2000, LLC

K-Number K213105

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DJG 2022-12-13

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

Applicant Shenzhen Superbio Technology Co., Ltd.

K-Number K220046

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FMI 2022-12-13

CCBIO ASCPO Needle

Applicant Cc Biotechnology Corporation

K-Number K214004

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ODP 2022-12-12

Matrix HA Fusion Porous Cervical IBF System

Applicant Innovasis, Inc.

K-Number K223510

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LTK 2022-12-12

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

Applicant Ortho Clinical Diagnostics

K-Number K221355

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HET 2022-12-12

SIRIUS Endoscope System

Applicant Precision Robotics (Hong Kong) Limited

K-Number K221642

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OVE 2022-12-12

Hive™ Standalone Cervical System

Applicant NanoHive Medical, LLC

K-Number K223190

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HWC 2022-12-12

Metal Bone Screw

Applicant Double Medical Technology, Inc.

K-Number K220921

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