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

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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JWH 2021-07-13

Physica LMC Knee System

Applicant Limacorporate

K-Number K211938

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PHX 2021-07-12

Bone Screws dia. 5,0 mm

Applicant Lima Corporate S.P.A.

K-Number K210717

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BZD 2021-07-12

Magneto Nasal Mask

Applicant Respironics, Inc.

K-Number K210386

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GEI 2021-07-12

InMode RF Pro System

Applicant Inmode MD , Ltd.

K-Number K210492

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