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

Bipolar Coagulation Foreceps

Hangzhou AGS MedTech Co., Ltd.

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope

Pentax of America, Inc.

Sleepio®

Big Health, Inc.

ZEN-2090 Turbo

Genoray Co., Ltd.

Erchonia Zerona® VZ8

Erchonia Corporation

Transpara 1.7.2

Screenpoint Medical B.V.

METIC™- Airway Balloon Catheter

M/S Meril Life Sciences Pvt. , Ltd.

Actera™ hip system

Conformis, Inc.

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

Depuy Mitek

VBrain

Vysioneer, Inc.

ME-APDS™; MAGENTIQ-COLO™

Magentiq Eye, Ltd.

SpineAR SNAP (SyncAR Spine)

Surgical Theater, Inc.

VenSure LightGuide

Intersect Ent.

Kyphoplasty Balloon Catheter

Jiangsu Changmei Medtech Co., Ltd.

Surgical Masks

Hubei Xinxin Non-Woven Co., Ltd.

Treace Medical Concepts (TMC) Implant Fixation System

Treace Medical Concepts

NPseal

Guard Medical, Inc.

MedCAD® AccuStride™ System

Medcad

XVbeam2000

Shenzhen Xpectvision Technology Co., Ltd.

FiteBac CC OrthoSeal

Largent Health, LLC

Erbe's Tubing/Cap Sets

Erbe USA, Inc.

TrachCuff Cuff Controller

Aw Technologies Aps

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

Medtronic, Inc.

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Topzir Biotech Co., Ltd.

Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

CMT Health PTE., Ltd.

Scooter (YD-03)

Yurob Rehabilitation Medical Co., Ltd.

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Laboratorios Biogalenic S.A. DE C.V.

APTUS Clavicle System 2.8

Medartis AG

Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0

Boston Scientific Corporation

Shoulder Soft Tissue Anchors

Signature Orthopaedics Pty, Ltd.

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