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
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye, Ltd.
Control-IQ Technology
Tandem Diabetes Care, Inc.
The 5000 Compact Series Ultrasound Systems
Philips Ultrasound, LLC
BPS Wrist Fracture System
Orthonovis, Inc.
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
Exactech, Inc.
Permatage Flowable, Settable Hemostatic Bone Paste
Orthocon, Inc.
Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
Vitacore Industries, Inc.
OviTex PRS (Long-Term Resorbable)
TELA Bio, Inc.
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Dongguan Bohuikang Technology Co.,Ltd
Smartpump 3.0 Double Electric Breast Pump
Lansinoh Laboratories
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno, Inc.
Disposable Surgical Gown
Nanning Tecbod Biological Technology Co., Ltd.
BENCOX Mirabo Cup System
Corentec Co., Ltd.
GREEN
Phasor Health, LLC
ViewFlex Xtra ICE Catheter
Irvine Biomedical, A St. Jude Medical Company
Phasix ST Parastomal Hernia Mesh
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
Align Studio
Laon Medi, Inc.
cryoICE cryoXT cryoablation probe (cryoXT)
AtriCure, Inc.
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36
Karl Storz Endoscopy America, Inc.
Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc.
Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
Olympus Medical Systems Corporation
Triever16 Curve
Inari Medical
Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:
Zhuhai Pusen Medical Technology Co., Ltd.
SnapshotNIR model KD205
Kent Imaging, Inc.
RayFlow
Hexacath
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd.
Paragon 28 External Ring Fixation System
Paragon 28, Inc.
Pen Needle
Hh Global Technology, Inc.
STIMPOD NMS460 Nerve Stimulator
Algiamed Technologies USA, Inc.
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