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

JOW 2023-01-20

Capiflo 5001

Applicant K&L Distributing, Inc.

K-Number K222158

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FLL 2023-01-20

Digital Thermometer, Model: DT007, DT008

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K214077

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POL 2023-01-20

pRESET Thrombectomy Device

Applicant Phenox Limited

K-Number K222848

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KNW 2023-01-20

Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

Applicant Itp Innovative Tomography Products GmbH

K-Number K222462

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KRO 2023-01-20

Triathlon® Hinge Knee System

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K223528

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MBH 2023-01-20

GMK Sphere & GMK SpheriKA Cementless

Applicant Medacta International S.A.

K-Number K223548

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QBD 2023-01-19

Biosci Inactivated Transport Medium, Biosci ITM

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K-Number K220059

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MRG 2023-01-19

Access 25(OH) Vitamin D Total

Applicant Beckman Coulter, Inc.

K-Number K223503

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OVD 2023-01-19

EL CAPITAN Anterior Lumbar Interbody Fusion

Applicant Astura Medical

K-Number K222554

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GXY 2023-01-19

Disposable Non-invasive EEG Sensor

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K220448

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OLO 2023-01-19

TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)

Applicant Medos International SARL

K-Number K223108

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LNS 2023-01-19

LM-9300 Plus Lithotripter

Applicant Lite-Med, Inc.

K-Number K213772

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