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

ITI 2021-03-17

Magic 360 Power Wheelchair

Applicant Magic Mobility

K-Number K203083

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MAX 2021-03-17

ProLift Wedge Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K203361

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LZA 2021-03-17

Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid

Applicant Shen Wei USA, Inc.

K-Number K202082

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LZA 2021-03-16

Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors

Applicant Shen Wei USA, Inc.

K-Number K202086

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BTT 2021-03-16

F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K201723

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NHA 2021-03-16

Multi-unit Abutments for CONELOG

Applicant BioHorizons Implant Systems, Inc.

K-Number K203252

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FXX 2021-03-16

MIPLNI YK-244 Disposable Surgical Mask

Applicant Hunan Yuankang Biological Technology Co., Ltd.

K-Number K210487

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NLQ 2021-03-16

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

Applicant Stryker Sustainability Solutions

K-Number K202554

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MQV 2021-03-15

DB-Composite

Applicant Dimensional Bioceramics, LLC

K-Number K210193

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DZE 2021-03-15

Neodent Implant System-Easy Pack

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K203382

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FXX 2021-03-15

Single-Use Surgical Mask

Applicant Qiqihar Hengxin Medical Supplies, Ltd.

K-Number K201924

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KGE 2021-03-15

Ensure Single-Use Coagulation Forceps

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K202438

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