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

GGP 2018-09-07

INNOVANCE Free PS Ag

Applicant Siemens Healthcare Diagnostics Products GmbH

K-Number K181525

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KNY 2018-09-07

Bi-Flex Evo

Applicant Promepla Sam

K-Number K182144

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MWI 2018-09-07

Philips Hemodynamic Application R1.0

Applicant Philips Medical Systems Nederlands B.V.

K-Number K181311

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IZI 2018-09-07

GLOW800

Applicant Leica Microsystems (Schweiz) AG

K-Number K181537

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HWC 2018-09-07

SILVERBACK Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K182148

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PQM 2018-09-07

Ultravision™ Visual Field Clearing System

Applicant Alesi Surgical, Ltd.

K-Number K182053

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FED 2018-09-07

ReTrace Ureteral Access Sheath

Applicant Coloplast A/S

K-Number K181811

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FRO 2018-09-07

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

Applicant Amsino International, Inc.

K-Number K181423

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IYE 2018-09-07

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

Applicant Medtec Inc. Dba Civco Medical Solutions

K-Number K182079

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LLZ 2018-09-07

syngo.via View&GO (Version VA10A)

Applicant Siemens Healthcare GmbH

K-Number K182208

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OHT 2018-09-07

IPL Hair Removal Device Joy Version

Applicant Shen Zhen Cosbeauty Co., Ltd.

K-Number K173813

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LLZ 2018-09-07

mediCAD 4.0

Applicant Medicad Hectec GmbH

K-Number K170702

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