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

QDQ 2021-03-12

ProFound AI Software V3.0

Applicant Icad, Inc.

K-Number K203822

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HET 2021-03-12

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

Applicant Schoelly Fiberoptic GmbH

K-Number K201617

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HQC 2021-03-12

VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control

Applicant Johnson & Johnson Surgical Vision, Inc.

K-Number K203060

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MUJ 2021-03-12

Oncospace

Applicant Oncospace, Inc.

K-Number K202284

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OKS 2021-03-11

Ritleng®+ and Ritleng®+ PVP

Applicant Fci (France Chirurgie Instrumentation) Sas

K-Number K201892

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GEX 2021-03-11

Fiber Dust

Applicant Quanta System Spa

K-Number K210142

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PHZ 2021-03-11

wheezo WheezeRate Detector

Applicant Respiri Limited

K-Number K202062

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QNW 2021-03-11

Monarch Bronchoscope

Applicant Auris Health, Inc., A Johnson and Johnson Family Company

K-Number K203614

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NGX 2021-03-11

miha bodytec II

Applicant Miha Bodytec GmbH

K-Number K201975

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PZP 2021-03-11

AquaBeam Robotic System

Applicant Procept Biorobotics, Corporation

K-Number K202961

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MBI 2021-03-11

Stryker ProCinch Adjustable Loop Device

Applicant Stryker Endoscopy

K-Number K210078

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MUU 2021-03-11

Smart Kit Basic, Smart Kit Pro

Applicant Bsl Co., Ltd.

K-Number K202443

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