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

DQO 2021-12-21

Progreat Lambda

Applicant Terumo Clinical Supply Co., Ltd.

K-Number K211078

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CCJ 2021-12-21

iCOquit® Smokerlyzer®

Applicant Bedfont Scientific, Ltd.

K-Number K211918

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QDQ 2021-12-21

BU-CAD

Applicant Taihao Medical, Inc.

K-Number K210670

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HSB 2021-12-21

The Progen™ Trochanteric Nail System

Applicant Ortho Development Corporation

K-Number K211086

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FEN 2021-12-21

CT3000Pro

Applicant Srs Medical

K-Number K212830

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LPH 2021-12-20

Mpact® 3D Metal Implants - DMLS Technology

Applicant Medacta International S.A.

K-Number K202568

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FXX 2021-12-20

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)

Applicant National Bridge Industrial (S.Z.) Co., Ltd.

K-Number K211750

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KDL 2021-12-20

Servator M SALF Solution

Applicant S.A.L.F. Spa

K-Number K211842

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GEX 2021-12-20

Frax 1940 for Nordlys and Frax Pro

Applicant Candela Corporation

K-Number K212492

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OHT 2021-12-20

IPL Home Use Hair Removal Device

Applicant Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.

K-Number K211185

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NCX 2021-12-20

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

Applicant Zoll Circulation, Inc.

K-Number K213031

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OMP 2021-12-20

3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)

Applicant 3M Healthcare Business Group

K-Number K211521

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