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

LLZ 2018-12-06

IntelliSpace Radiology

Applicant Philips Healthcare Informatics, Inc.

K-Number K182926

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JWH 2018-12-06

EVOLUTION Stemmed CS Femur

Applicant Microport Orthopedics, Inc.

K-Number K182125

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PJA 2018-12-06

FFRct

Applicant HeartFlow, Inc.

K-Number K182035

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HIH 2018-12-06

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

Applicant Hologic, Inc.

K-Number K182006

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QDQ 2018-12-06

PowerLook Tomo Detection V2 Software

Applicant Icad, Inc.

K-Number K182373

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LIT 2018-12-06

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Applicant Contego Medical, LLC

K-Number K181529

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MAX 2018-12-06

DePuy Synthes T-PAL Spacer System

Applicant Depuy Synthes Spine

K-Number K181231

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FLL 2018-12-06

RII Smart IR Thermometer

Applicant Radiant Innovation, Inc.

K-Number K163601

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FLL 2018-12-06

No-contact Forehead Thermometer

Applicant Dongguan Simzo Electronic Technology Co., Ltd.

K-Number K173048

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FRO 2018-12-06

KerraContact Ag Perf Advanced Perforated Silver Wound Dressing

Applicant Exciton Technologies, Inc.

K-Number K182680

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LRK 2018-12-06

Elevo® Kit Snoring Intervention Device

Applicant Zelegent, Inc.

K-Number K181107

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NAY 2018-12-06

Senhance Surgical System

Applicant Transenterix, Inc.

K-Number K183098

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