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

MWI 2018-09-07

Philips Hemodynamic Application R1.0

Applicant Philips Medical Systems Nederlands B.V.

K-Number K181311

View Details →

IZI 2018-09-07

GLOW800

Applicant Leica Microsystems (Schweiz) AG

K-Number K181537

View Details →

HWC 2018-09-07

SILVERBACK Gorilla Plating System

Applicant Paragon 28, Inc.

K-Number K182148

View Details →

PQM 2018-09-07

Ultravision Visual Field Clearing System

Applicant Alesi Surgical, Ltd.

K-Number K182053

View Details →

FED 2018-09-07

ReTrace Ureteral Access Sheath

Applicant Coloplast A/S

K-Number K181811

View Details →

FRO 2018-09-07

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

Applicant Amsino International, Inc.

K-Number K181423

View Details →

IYE 2018-09-07

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

Applicant Medtec Inc. Dba Civco Medical Solutions

K-Number K182079

View Details →

LLZ 2018-09-07

syngo.via View&GO (Version VA10A)

Applicant Siemens Healthcare GmbH

K-Number K182208

View Details →

OHT 2018-09-07

IPL Hair Removal Device Joy Version

Applicant Shen Zhen Cosbeauty Co., Ltd.

K-Number K173813

View Details →

LLZ 2018-09-07

mediCAD 4.0

Applicant Medicad Hectec GmbH

K-Number K170702

View Details →

DQA 2018-09-07

Disposable SpO2 Sensors, Reusable SpO2 Sensors

Applicant Orantech, Inc.

K-Number K181270

View Details →

IPF 2018-09-07

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K181688

View Details →

Page 1997 of 2685

↑