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

MOS 2023-10-24

16 Breast Coil

Applicant Philips Medical System Nederlands B.V.

K-Number K233348

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DQX 2023-10-24

Steerant Super Stiff Guidewire

Applicant Medtronic Vascular

K-Number K232570

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OUR 2023-10-24

REUNION Sacroiliac Joint Fusion System

Applicant Astura Medical

K-Number K232211

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LLZ 2023-10-24

spineEOS

Applicant Eos Imaging

K-Number K232086

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DWJ 2023-10-24

FilteredFlo Warming Blankets

Applicant Iob Medical, Inc.

K-Number K232638

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FEO 2023-10-23

Swiss LthoClast Trilogy

Applicant E.M.S Electro Medical Systems S.A

K-Number K230893

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HKY 2023-10-23

Applanation Tonometer HT-5000

Applicant Huvitz Co., Ltd.

K-Number K232143

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MBI 2023-10-23

Shadow Knotless All-Suture Anchors

Applicant Responsive Arthroscopy, LLC

K-Number K233258

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LON 2023-10-23

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

Applicant bioMerieux, Inc.

K-Number K232201

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NKB 2023-10-23

Ripley Spinal Screw System by SAGICO

Applicant Sagico VA USA, LLC

K-Number K232561

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DXC 2023-10-23

PICOCLAMP

Applicant Kono Seisakusho Co., Ltd.

K-Number K230281

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QIH 2023-10-23

AI-Rad Companion Brain MR

Applicant Siemens Medical Solutions U.S.A.

K-Number K232305

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