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

NHA 2023-03-09

DESS Dental Smart Solutions

Applicant Terrats Medical SL

K-Number K221301

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QJP 2023-03-09

CEREGLIDE 71 Intermediate Catheter

Applicant Cerenovus, Inc.

K-Number K221930

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DQY 2023-03-09

CPS Locator 3D Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K230363

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LON 2023-03-09

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

Applicant Biomerieux Sa, Inc.

K-Number K222430

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JAK 2023-03-09

Spectral Bone Marrow

Applicant Ge Medical Systems, LLC

K-Number K223514

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ILY 2023-03-09

LED Lip Perfector, model: ZC-05

Applicant Light Tree Ventures Europe B.V.

K-Number K223642

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NRY 2023-03-09

CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set

Applicant Cerenovus, Inc.

K-Number K221934

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DRM 2023-03-09

AutoPulse NXT Resuscitation System

Applicant Zoll Circulation, Inc.

K-Number K221700

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QHE 2023-03-08

Arthrex Virtual Implant Positioning (VIP) System

Applicant Arthrex, Inc.

K-Number K222007

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FTC 2023-03-08

Enhanced AURORA Medical Diode System, and related accessories

Applicant Psoria-Shield, Inc.

K-Number K230076

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IRP 2023-03-08

Cryo-Thermo Compression Device (FGK002)

Applicant Suzhou Microport Rehabtech (Group) Co., Ltd.

K-Number K222136

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OMP 2023-03-08

extriCARE 1000 Negative Pressure Wound Therapy System

Applicant Alleva Medical, Ltd.

K-Number K213906

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