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

QJP 2024-12-19

Broadway 8 Catheter

Applicant Stryker Neurovascular

K-Number K241768

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FEB 2024-12-19

System 83 Revolve Endoscope Washer/Disinfector

Applicant Wassenburg Medical, Inc.

K-Number K241168

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QIH 2024-12-19

Saige-Density (2.5.0)

Applicant DeepHealth, Inc.

K-Number K243705

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JWY 2024-12-19

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL

Applicant Thermo Fisher Scientific

K-Number K243169

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QWO 2024-12-19

IQ-UIP

Applicant Imbio, Inc.

K-Number K242467

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OHS 2024-12-19

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)

Applicant Shenzhen Nuon Medical Equipment Co., Ltd.

K-Number K242700

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NHA 2024-12-19

IPD Dental Implant Abutments

Applicant Implant Protesis Dental 2004, S.L.

K-Number K242819

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FTM 2024-12-19

OviTex PRS (Long-Term Resorbable)

Applicant TELA Bio, Inc.

K-Number K243595

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QIH 2024-12-19

OrthoNext Platform System

Applicant Orthofix Srl

K-Number K242270

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QDQ 2024-12-19

Saige-Dx (3.1.0)

Applicant DeepHealth, Inc.

K-Number K243688

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NHN 2024-12-19

Therapy EC, Therapy XT

Applicant Dmc Importacao E Exportacao DE Equipamentos Ltda

K-Number K232813

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GEI 2024-12-19

Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

Applicant Medline Industries, LP

K-Number K242370

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