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

JWH 2022-05-10

Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)

Applicant Conformis, Inc.

K-Number K221059

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FPA 2022-05-10

Needle Free Connector

Applicant Medcaptain Life Science Co., Ltd.

K-Number K213004

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QEP 2022-05-10

BD CTGCTV2

Applicant Becton, Dickinson and Company

K-Number K210585

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LZA 2022-05-10

Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile

Applicant One Glove Industrial Sdn Bhd

K-Number K220428

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MYN 2022-05-10

Overjet Caries Assist

Applicant Overjet, Inc.

K-Number K212519

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LLZ 2022-05-10

inHEART MODELS

Applicant Inheart, Sas

K-Number K220727

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MAX 2022-05-10

SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System

Applicant SeaSpine Orthopedics Corporation

K-Number K220711

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LZA 2022-05-10

White Nitrile Powder-Free Patient Examination Glove, Non Sterile

Applicant One Glove Industrial Sdn Bhd

K-Number K220427

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DJG 2022-05-09

Immunalysis Tapentadol Urine HEIA

Applicant Lmmunalysis Corporation

K-Number K203527

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NJR 2022-05-09

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System

Applicant Cepheid

K-Number K203429

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EBW 2022-05-09

CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

Applicant Cefla S.C.

K-Number K213022

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GKZ 2022-05-09

Sight OLO

Applicant S.D. Sight Diagnostics , Ltd.

K-Number K211840

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