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

NHA 2022-11-10

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

Applicant Megagen Implant Co., Ltd.

K-Number K220562

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FYA 2022-11-10

Bodygard SFS Surgical Gown Level 4

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri

K-Number K221139

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QEW 2022-11-10

WOLF Thrombectomy™ SmartClaw Catheter

Applicant Devoro Medical, Inc.

K-Number K221391

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MQC 2022-11-10

Dental LT Clear V2 Resin

Applicant Formlabs Ohio, Inc.

K-Number K222061

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KDI 2022-11-10

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Applicant Quanta Dialysis Technologies, Ltd.

K-Number K222067

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NFT 2022-11-10

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K222667

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QKB 2022-11-10

AVIEW RT ACS

Applicant Coreline Soft Co., Ltd.

K-Number K220408

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KWS 2022-11-10

Catalyst EA Convertible Stemmed Shoulder

Applicant Catalyst Orthoscience, Inc.

K-Number K222317

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EOQ 2022-11-10

FUJIFILM Endoscope Model EB-710P

Applicant Fujifilm Corporaton

K-Number K220957

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MHC 2022-11-10

BD Intraosseous Vascular Access System EMS Powered Driver (D001003)

Applicant Bard Access Systems

K-Number K223198

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OCX 2022-11-10

AquaPulse® Irrigation Tubing

Applicant Ga Health Company Limited

K-Number K223171

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LRK 2022-11-10

SNOR LOCK

Applicant Solbaro Co., Ltd.

K-Number K222475

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