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

KOB 2019-01-18

Cook Cystostomy Catheter Set

Applicant Cook Incorporated

K-Number K181097

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OWQ 2019-01-18

Reprocessed Visions PV .035 Digital IVUS Catheter

Applicant Innovative Health, LLC

K-Number K181126

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LNH 2019-01-18

Magnetom Vida

Applicant Siemens Medical Solutions USA, Inc.

K-Number K183254

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BTL 2019-01-18

Puffin Lite Infant Resuscitation System

Applicant International Biomedical

K-Number K182956

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FPD 2019-01-18

VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)

Applicant Vr Medical Technology Co., Ltd.

K-Number K180236

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MUE 2019-01-18

Pristina Serena 3D

Applicant GE Healthcare

K-Number K182951

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KYF 2019-01-18

AHMED ClearPath Glaucoma Drainage Device

Applicant New World Medical, Inc.

K-Number K182518

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GCJ 2019-01-18

Flex-THOR scope

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K183264

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FDF 2019-01-18

PENTAX Video Colonoscopes (EC Family)

Applicant Pentax of America, Inc.

K-Number K181084

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NAY 2019-01-18

SureForm 45, SureForm 45 Reloads

Applicant Intuitive Surgical

K-Number K183224

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LNH 2019-01-18

SIGNA Premier

Applicant Ge Medical Systems, LLC

K-Number K183231

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MBI 2019-01-18

Responsive Arthroscopy Wedge Push-In Suture Anchors

Applicant Responsive Arthroscopy, LLC

K-Number K181076

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