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
Ambu® Virobac II® Exhalation Filter
Ambu A/S
Signature ONE System
Orthosoft Inc. (D/B/A) Zimmer Cas)
restor3d Reverse Total Shoulder Arthroplasty System
Restor3D
Customize
3D-Side S.A.
TurbAlign
Spirair, Inc.
OBSIDIO Conformable Embolic
Boston Scientific Corporation
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Intelligence LaserComb
Yibin Yingtong Intelligent Technology Co., Ltd.
Dukal SMS Sterilization Wrap
Dukal, LLC
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Spur Peripheral Retrievable Stent System
Reflow Medical, Inc.
Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd.
Soniquence Reusable 3 Button Fingerswitch Wand
Soniquence, LLC
C-Stem AMT LE Prosthesis
Depuy Ireland UC
CoolTone
Zimmer Medizinsysteme GmbH
REDEMPTION Beaming System
Vilex, LLC
SCAR 3
El.En Electroinc Engineering Spa
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
F&P Optiflow Flow Diverter
Fisher & Paykel Healthcare, Ltd.
Momcozy Wearable Breast Pump (BP311)
Shenzhen Root Innovation Technology Co., Ltd.
Syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
Hope&Her Vaginal Dilators
Lujena, Inc.
ShiNeo Silicone Implant
Shineo Technology Co., Ltd.
uNion® MAX Cervical Plate System
Ulrich Medical USA, Inc.
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Technologies, Inc.
17HQ701G-B
Lg Electronics.Inc
Solo+ Tympanostomy Tube Device (TTD)
Aventamed Dac
AAMI3 Isolation Gown
Hubei Xinxin Non-Woven Co., Ltd.
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
Yibin Junxin Electronics Technology Co., Ltd.
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
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