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

UV Smart D60

UV Smart Technologies B.V.

PRIMED Pediatric Facemask

Primed Medical Products, Inc.

Transcutaneous Electrical Nerve Stimulator (K6106)

Shenzhen Yicai Health Technology Co., Ltd.

DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder);

Kamemizu Chemical Industry Co., Ltd.

Dynamis Pro Family

Fotona D.O.O.

Medical surgical mask

Guangdong Kingfa Sci. & Tech.Co., Ltd.

Accuro® 3S Needle Guide Kit

Rivanna Medical, Inc.

StitchKit

Origami Surgical Inc .

PIUR tUS inside

Piur Imaging GmbH

ACR Screw System

Biomaterials Korea, Inc.

Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate

Luliang Hongruida Health Protection Technology Co., Ltd.

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

Acuity Polymers, Inc.

Extra Silver Gelling Fiber Dressing

Winner Medical Co., Ltd.

AltiVate® Anatomic Shoulder AG e+™ with Markers

Encore Medical L.P.

OsteoProbe

Active Life Scientific, Inc.

Suction Pump (SU-90)

Shenzhen HugeMed Medical Technical Development Co., Ltd.

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

Stryker GmbH

Aperio GT 450 DX

Leica Biosystems Imaging, Inc.

Access Thyroglobulin

Beckman Coulter, Inc.

Tyto Insights for Rhonchi Detection

Tyto Care , Ltd.

Medical Nitrile Examination Gloves

Jiangxi Ronglai Medical Technology Co., Ltd.

Perceptive electric dental motor and control unit

Lares Research

Eminent Spine 3D Lumbar Interbody Fusion Systems

Eminent Spine, LLC

Patient Specific Planning Solution™ 3D Bone Models

Biomet Manufacturing Corp

Aptiva APS IgA Reagent

Inova Diagnostics, Inc.

DenMat Glutaraldehyde Desensitizer

Denmat Holding, LLC

Curian Campy

Meridian Bioscience, Inc.

NeuroSwift Pro

Neurobit Technologies Co., Ltd.

Samsung ECG App v 1.3 (ECG)

Samsung Electronics Co., Ltd.

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Cathete

Medsource International, LLC

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