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

PML 2017-10-23

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

Applicant Medtronic

K-Number K171938

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DRF 2017-10-23

Reprocessed Inquiry Steerable Diagnostic EP Catheter

Applicant Innovative Health, LLC

K-Number K171277

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DHA 2017-10-23

Alinity i Total ß-hCG Reagent Kit, Alinity i System

Applicant Abbott Laboratories

K-Number K170317

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GEI 2017-10-23

gi-4000 Electrosurgical Generator

Applicant United States Endoscopy Group, Inc.

K-Number K172805

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NKB 2017-10-23

AnyPlus® Spinal Fixation System

Applicant GS Medical Co., Ltd.

K-Number K172546

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OVE 2017-10-23

Acapella Cervical Spacer System

Applicant Choicespine, LP

K-Number K171489

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OBJ 2017-10-23

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

Applicant Acist Medical Systems, Inc.

K-Number K173063

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MBI 2017-10-23

M-ARS ACL: Anatomic Ribbon Surgery System

Applicant Medacta International S.A.

K-Number K171640

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IYO 2017-10-20

Accuro

Applicant Rivanna Medical, LLC

K-Number K171594

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KGO 2017-10-20

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove

Applicant Lucenxia Prescience AG

K-Number K171987

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MUE 2017-10-20

Adani MammoScan

Applicant Adani

K-Number K172027

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GEX 2017-10-20

NeuroBlate System

Applicant Monteris Medical,

K-Number K172881

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