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

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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LZH 2023-10-23

Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set

Applicant Vesco Medical, LLC

K-Number K232205

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GEI 2023-10-23

CleanSeal Advanced Bipolar Vessel Sealer Maryland

Applicant Conmed Corporation

K-Number K231732

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LNH 2023-10-23

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231560

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IYN 2023-10-23

Ultrasound System 1300

Applicant Bk Medical Aps

K-Number K231764

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NUC 2023-10-22

JO Coconut Hybrid Cooling Personal Lubricant

Applicant CC Wellness, LLC

K-Number K232091

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POL 2023-10-21

pRESET LITE Thrombectomy Device

Applicant Phenox Limited

K-Number K231539

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QIH 2023-10-20

Sonix Health

Applicant Ontact Health Co., Ltd.

K-Number K230209

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LLZ 2023-10-20

R2GATE Lite TM

Applicant Megagen Implant Co., Ltd.

K-Number K223909

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