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

PZM 2021-07-14

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

Applicant Nyu Langone Medical Center

K-Number K202304

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FXX 2021-07-14

Surgical Face Mask, Surgical Mask

Applicant Lear Corporation

K-Number K201844

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DFH 2021-07-14

N Latex FLC kappa, N Latex FLC lambda

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K193047

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OHS 2021-07-14

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

Applicant Ningbo Hesi Electric Co., Ltd.

K-Number K200983

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OLO 2021-07-14

ARVIS Surgical Navigation System

Applicant Insight Medical Systems, Inc.

K-Number K203115

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LPH 2021-07-14

Provident II Hip Stems

Applicant Globus Medical, Inc.

K-Number K201733

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NKB 2021-07-14

Pisces Spinal System

Applicant Ortho Development Corporation

K-Number K203023

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LKP 2021-07-14

EliA SmDP-S

Applicant Phadia AB

K-Number K202067

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EMA 2021-07-13

UltraTemp Rez II

Applicant Ultradent Products, Inc.

K-Number K211237

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ITI 2021-07-13

Electric Wheelchair [Models: JRWD6010/JRWD6012]

Applicant Jerry Medical Instrument (Shanghai) Co., Ltd.

K-Number K192739

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DHA 2021-07-13

ADVIA Centaur® Total hCG assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K200210

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NBW 2021-07-13

Finetest Lite Blood Glucose Monitoring System

Applicant Osang Healthcare Co. , Ltd.

K-Number K203562

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