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

Air Compression Leg Massager (K-705)

Jiale Health Technology Shenzhen Co., Ltd.

Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2

Shenzhen Kentro Medical Electronics Co., Ltd.

POLARSTEM Calcar Reamer Guide

Smith & Nephew, Inc.

SCORPION Portal Vein Access Set

Argon Medical Devices

Sterile syringes for single use with/without needle

Wepon Medical Technology Co., Ltd.

VOCO Retraction Paste

Voco GmbH

FlightPlan for Embolization

GE Medical Systems SCS

Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B);

Shenzhen AOJ Medical Technology Co., Ltd.

EXPLORER AIR® II

Surgvision GmbH

Porous Biologic Scaffold

Ventris Medical

AutoContour (RADAC V5)

Radformation, Inc.

Invitae Common Hereditary Cancers Panel

Invitae Corporation

Plasma IQ

Neauvia North America, Inc.

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

Siemens Healthcare Diagnostics, Inc.

BD BACTEC FXI Culture System

BD Diagnostic Systems

AxTiHA Stand-Alone ALIF System

Innovasis, Inc.

HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4

Bracco Diagnostics, Inc.

PreXion3D Explorer PRO

Prexion Corporation

Pump In Style® Pro+

Medela, LLC

Metal Bone Screw

Double Medical Technology, Inc.

ds Head 32ch 3.0T

Invivo Corporation (Business Trade Name: Philips)

STARband 3D

Orthomerica Products, Inc.

Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System

Medtronic, Inc.

MONTAGE Settable, Resorbable Bone Putty

Orthocon, Inc.

U2 Total Knee System-PF+

United Orthopedic Corporation

Allure Hip Stem and Intramedullary Plugs

Waldemar Link GmbH & Co. KG

V-Patch Cardiac Monitor

Shandong Corecare Technology Limited

OcuCool

Recensmedical, Inc.

Point implant system

Pointnix Co., Ltd.

FiberTak® Suture Anchor

Arthrex, Inc.

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