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.)
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