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

LZA 2022-03-09

Disposable Medical Nitrile gloves

Applicant Guangdong Xingcan Brothers Medical Technology Co.,Ltd

K-Number K213851

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MAX 2022-03-09

PathLoc Lumbar Interbody Fusion Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K213441

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GCJ 2022-03-09

4K UHD LCD Monitor OEV321UH

Applicant Olympus Medical Systems Corp.

K-Number K220069

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MAX 2022-03-09

Genesys Spine 3DP Lumbar Interbody System

Applicant Genesys Spine

K-Number K220096

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BZD 2022-03-09

Auto CPAP System

Applicant BMC Medical Co., Ltd.

K-Number K211155

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OWB 2022-03-09

ZEN-2090 Turbo

Applicant Genoray Co., Ltd.

K-Number K211780

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DQY 2022-03-09

Amplatzer Steerable Delivery Sheath

Applicant ABBOTT MEDICAL

K-Number K220340

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LPH 2022-03-09

Acetabular Dome Hole Plug

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K220376

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FMF 2022-03-09

BD Insulin Syringe (0.3mL)

Applicant Becton, Dickinson and Company

K-Number K212499

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NUH 2022-03-08

TENS & EMS DEVICE (Model: FM-B2403A)

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K-Number K213741

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KTI 2022-03-08

Elation Pulmonary Balloon Dilation Catheter

Applicant Merit Medical Systems, Inc.

K-Number K213434

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EZD 2022-03-08

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

Applicant Coloplast

K-Number K203637

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