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
JETT Medical II
Compex, Spol, S.R.O.
IntraOp VSP Software Device
Xironetic, LLC
HALO AP Dx
Indica Labs, Inc.
Altus Spine Monaco Pedicle Screw System
Altus Spine
Us2.v2
Eko.Ai Pte Ltd. D/B/A Us2.Ai
SURGIVISIO Device
Ecential Robotics
Aveli
Nc8, Inc.
LuMon(TM) System
Sentec AG
dS Knee Coil 8ch 1.5T
Philips Medical Systems Nederland B.V.
TENSOR® Suture Button System
Globus Medical, Inc.
Eonis SCID-SMA kit
Perkinelmer, Inc.
Vial2Bag Advanced® 13mm Admixture Device
West Pharma. Services IL, Ltd.
EXPERT - Flexible Joint Fixation System
GM Dos Reis Industria e Comercio Ltda.
Intai Anatomic Locking Plate and Screw System
Intai Technology Corporation
Klär Lite (RCW-KL1000)
Radcliffe Watts, LLC
Introducer Sheath Set
Cardiocycle Medical(Suzhou) Co., Ltd.
NovaLine Tubing Set for Hemodialysis (BL 124)
Bain Medical Equipment (Guangzhou) Co., Ltd.
Arthrex Mini Fragment System
Arthrex, Inc.
IOB Warming Blankets
Iob Medical, Inc.
Modular Medical MODD1 Insulin Delivery System
Modular Medical, Inc.
Jabra Enhance Select Self-fit (Jabra Enhance Select 550)
GN Hearing A/S
Coconut Hybrid
Good Clean Love, Inc.
GUS610 Blood pressure monitor
Globalcare Medical Technology Co., Ltd.
Suture-TOOL System
Suturion AB
NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
Anhui Jbh Medical Apparatus Co., Ltd.
V8 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Nihon Kohden NKV-440 Ventilator System
Nihon Kohden Orangemed, Inc.
Disposable Insulin Pen Needle
Ningbo Medsun Medical Co., Ltd.
TriMed Threaded Intramedullary Nail System
TriMed, Inc.
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