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

LZO 2021-01-11

M-Vizion Femoral Revision System Extension

Applicant Medacta International S.A.

K-Number K201471

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NKB 2021-01-11

GetSet Surgical GoPLF! Posterior Lateral Fusion System

Applicant Getset Surgical, SA

K-Number K202505

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KNW 2021-01-11

Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm

Applicant Biopsybell S.R.L.

K-Number K203397

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FXX 2021-01-11

Medical Surgical Mask-Model MP002-5, MP002-6

Applicant Jiangmen Sure&Me Medical Product Co., Ltd.

K-Number K202577

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LDD 2021-01-11

Switched Internal Paddles

Applicant Philips North America, LLC

K-Number K203231

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QNL 2021-01-09

CLEWICU System (ClewICUServer and ClewICUnitor)

Applicant Clew Medical , Ltd.

K-Number K200717

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BSK 2021-01-09

Puritan Bennett Cuff Pressure Manager

Applicant Covidien, LLC

K-Number K202874

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IYN 2021-01-08

LOGIQ P10, LOGIQ P9, LOGIQ P8

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K203114

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OAT 2021-01-08

OBS Anchorage Screw, Biokey Anchorage Screw

Applicant Bomei Co, Ltd.

K-Number K202278

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ODC 2021-01-08

BioGuard Air/Water and Suction Valves

Applicant Steris Corporations

K-Number K203630

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HRS 2021-01-08

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System

Applicant Wrightmedicaltechnologyinc

K-Number K201259

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PJA 2021-01-08

HeartFlow Analysis

Applicant HeartFlow, Inc.

K-Number K203329

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