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

DNA/RNA Shield SafeCollect Saliva Collection kit

Zymo Research

Disposable Surgical Mask (non sterile)

Qinhuangdao Taizhi Medical Technology Co., Ltd.

GalaFLEX LITE Scaffold

Tepha, Inc.

BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Nee

Becton Dickinson Infusion Therapy Systems, Inc.

FemVue® Controlled Saline-Air Device (FSA-300)

Femasys, Inc.

Arm Blood Pressure Monitor

Alicn Medical Shenzhen, Inc.

MIRARI® Cold Plasma System ( GV-M2-01)

General Vibronics, Inc.

Quicktome Software Suite

Omniscient Neurotechnology Pty Ltd (O8t)

ONVOY™ Acetabular System

Globus Medical, Inc.

ALIGN Radial Head System

Skeletal Dynamics, Inc.

UltraClear Fractional Laser System

Fa International, LP

VOCO Retraction Paste

Voco GmbH

Customized Abutment

Arum Dentistry Co., Ltd.

DePuy CONDUIT LLIF SQUID Inserter

Enztec Limited

SAGICO Spinal System

Sagico VA USA, LLC

eMVFit (MVF-10M)

Weero Co., Ltd.

AITRICS-VC

Aitrics Co., Ltd.

RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large

Smith and Nephew Medical Limited

Elvie Stride

Chiaro Technology Limited

Air Smart Extra Spirometer

Feellife Health, Inc.

Verifine® Pen Needles

Promisemed Hangzhou Meditech Co., Ltd.

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

Canon Medical Systems Corporation

SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

Immunalysis Corporation

Freedom® Total Knee System

Maxx Orthopedics, Inc.

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)

Alliage S/A Industrias Médico Odontológica

ApolloKnee

Corin U.S.A. Limited

Ecomed Disposable Administration Sets

Ecomed Solutions, LLC

Accu-Chek Safe-T-Pro Plus Lancing Device

Roche Diabetes Care, Inc.

GT5 conductive & abrasive gel

Wuhan Greentek Pty , Ltd.

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

Alma Lasers, Inc.

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