RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Lipocosm Harmonic System

Lipocosm, LLC

EzVu Visual Vasopressor injector (EV-19)

Veol Medical Technologies Pvt , Ltd.

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization Sy

Steris

BPBIO750

Inbody Co., Ltd.

Vinyl Patient Examination Gloves

Jiangxi Shengda Medical Technology Co., Ltd.

Curiteva Porous PEEK Laminoplasty System

Curiteva, Inc.

Symbia VA10A Family

Siemens Medical Solutions USA, Inc.

LGO-Surgical Laser Fibers

Light Guide Optics International , Ltd.

Anovo Surgical System (6Ne)

Momentis Surgical , Ltd.

Community Containers (Flap and Daisy)

Keter Canada, Inc.

Zeta Navigation System

Zeta Surgical, Inc.

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Philips Medical Systems Nederland B.V.

Medline Orbis Chemo Surgical Gown

Medline Industries, LP

SteriBest® Sterilization Tray System

Mastel Surgical

AXIOS Stent and Electrocautery-Enhanced Delivery System

Boston Scientific Corporation

Bonvadis Topical Cream

Stemcyte, Inc.

Talee, Talee PostOp

Invent Medical USA, LLC

Synapse Lung Nodule AI

Fujifilm Corporation

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01,

Remington Medical, Inc.

Agile Esophageal Stent System

Boston Scientific Corporation

Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)

Spectrum Medical S.R.L.

Perfit CL

Vatech Mcis Co., Ltd.

Rayvolve

Azmed Sas

Transpara Density 1.0.0

Screenpoint Medical B.V.

Mobility Scooter (X-12, X-14, X-17)

Wuyi Aichi Industry and Trade Co., Ltd.

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

Hathor Professional Skincare , Ltd.

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

STERIS Corporation

PELNAC Meshed Bilayer Wound Matrix

Gunze Limited

Yumizen H2500

HORIBA ABX SAS

SternalPlate Expansion

Stryker Leibinger GmbH & Co KG

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