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

JOZ 2019-03-29

AggreGuide A-100 ADP

Applicant Aggredyne, Inc.

K-Number K181777

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JAA 2019-03-29

CS-series-FP with Optional ROI Accessory CA-100S

Applicant Omega Medical Imaging, LLC

K-Number K182834

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MUJ 2019-03-29

Monaco RTP System

Applicant Elekta, Inc.

K-Number K190178

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IYO 2019-03-28

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K-Number K190186

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HIF 2019-03-28

AirSeal

Applicant Conmed Corporation

K-Number K190303

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FDT 2019-03-28

FUJIFILM Duodenoscope Model

Applicant Fujifilm Corporation

K-Number K181745

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OMP 2019-03-28

V.A.C. DERMATAC Drape

Applicant Kci USA, Inc.

K-Number K181505

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QFP 2019-03-28

LOADPRO Intraoperative Rod Strain Sensor

Applicant Intellirod Spine, Inc.

K-Number DEN180012

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KGO 2019-03-28

Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs

Applicant Pt. Medisafe Technologies

K-Number K182176

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QFX 2019-03-28

Leica FL400

Applicant Leica Microsystems (Schweiz) AG

K-Number DEN180024

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MBI 2019-03-27

Responsive Arthroscopy Wedge Push-In Suture Anchors

Applicant Responsive Arthroscopy, LLC

K-Number K190446

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FLE 2019-03-27

AMSCO 600 Steam Sterilizer

Applicant STERIS Corporation

K-Number K183410

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