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

FEB 2022-01-14

SCOPE BUDDY PLUS Endoscope Flushing Aid

Applicant Medivators, Inc.

K-Number K213833

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QHW 2022-01-14

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K201057

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OLO 2022-01-14

iASSIST Knee System

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K213033

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ODC 2022-01-14

Wellead Endoscopic Seal

Applicant Well Lead Medical Co., Ltd.

K-Number K211814

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OBJ 2022-01-14

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

Applicant Boston Scientific Corporation

K-Number K213593

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EBG 2022-01-14

UltraPrint-Dental Temp C&B UV

Applicant Guangzhou Heygears IMC., Inc.

K-Number K213643

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MQB 2022-01-14

Eclipse II with Smart Noise Cancellation

Applicant Carestream Health, Inc.

K-Number K213307

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DQA 2022-01-14

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Applicant Shenzhen Narig Bio-Medical Technology Co., Ltd.

K-Number K211632

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FXX 2022-01-14

Surgical Mask

Applicant Guangdong Zhizhen Biological Medical Co., Ltd.

K-Number K212997

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OMP 2022-01-14

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Applicant Smith & Nephew Medical Limited

K-Number K202783

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MWI 2022-01-14

Capsule Surveillance System

Applicant Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.

K-Number K213335

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GEI 2022-01-14

Medline Universal Grounding Pad

Applicant Medline Industries, Inc.

K-Number K212093

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