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

Plum Duo™ Precision IV Pump

Icu Medical, Inc.

Anterion

Heidelberg Engineering GmbH

TruPlan Computed Tomography (CT) Imaging Software

Circle Cardiovascular Imaging, Inc.

Safety Pen Needle

Sandstone Medical (Suzhou), Inc.

Auxilock Titanium Screw-In Suture Anchor

Auxein Medical Private Limited

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets

Cook Medical

Restoration® Modular Hip System

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Cryopush Cold Compression Device

Chengdu Cryo-Push Medical Technology Co.,Ltd

ARIX Pectus Bar System

Jeil Medical Corporation

BD Insulin Syringe (0.3mL)

Becton, Dickinson and Company

Dawn Diode Laser System

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

Ever Fortune.Ai, Co., Ltd.

Revital-Ox PAA High Level Disinfectant Chemical Indicator

STERIS Corporation

DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)

Devilbiss Healthcare, LLC

Viz AAA

Viz. Ai, Inc.

Butterfly Gestational Age Tool

Butterfly Network, Inc.

InBody Blood pressure monitor, Model BPBIO480KV

Inbody Co., Ltd.

Cirq Arm System (2.0);Alignment System Spine

Brainlab AG

Bard® Mesh; Bard® Mesh Pre-Shaped

Davol, Inc.

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

Brainlab AG

APEX 3D Total Ankle Replacement System

Paragon 28, Inc.

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

Wuhan Pioon Technology Co., Ltd.

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

Huizhou Tianchang Industrial Co., Ltd.

Caas Qardia

Pie Medical Imaging BV

ProVee Video Processing Unit (PV-003)

Proverum Limited

CARTO™ 3 EP Navigation System V8.4

Biosense Webster, Inc.

LifePath Remote Patient Monitoring Platform

Elastic Care Incorporated

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is

Shenzhen Beacon Display Technology Co., Ltd.

Naviswiss Knee

Naviswiss AG

AccuCath Ace™ Intravascular Catheter

Bard Access Systems, Inc. (C.R. Bard, Inc.)

← PrevPage 78 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert