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

MAX 2022-08-17

TDM Lumbar Interbody Fusion Cage System

Applicant Tdm Co., Ltd.

K-Number K221844

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FXX 2022-08-17

Surgical Face Mask (HNFM0103)

Applicant Shanghai Hua EN Industrial Co, Ltd.

K-Number K221838

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LLZ 2022-08-17

WebCeph

Applicant Assemblecircle Corp.

K-Number K220903

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LZO 2022-08-17

implaFit® hip stems

Applicant Implantcast GmbH

K-Number K210678

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HAW 2022-08-17

Disposable Brain Biopsy Needle 2.0

Applicant PAJUNK GmbH Medizintechnologie

K-Number K220897

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FXX 2022-08-17

Cross Protection ResQ300 Plus Surgical Face Mask

Applicant Cross Protection (M) Sdn Bhd

K-Number K212273

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FMF 2022-08-17

Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K212033

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KOI 2022-08-17

Tetragraph Neuromuscular Transmission Monitor

Applicant Senzime AB

K-Number K220530

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DQK 2022-08-17

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

Applicant Biosense Webster, Inc.

K-Number K221112

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QRL 2022-08-17

Disposable Blood Lancets

Applicant Suzhou Kyuan Medical Apparatus Co., Ltd.

K-Number K220387

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QHE 2022-08-17

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K220452

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DQA 2022-08-16

YUWELL Finger Pulse Oximeter

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K-Number K212385

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