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
Intense Pulsed Light (IPL) System
Shenzhen Fansizhe Science and Technology Co., Ltd.
The Karma® Fixation System
Spinal Elements, Inc.
Nautilus
Dornier Medtech America, Inc.
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear
Yung Sheng Optical Co., Ltd.
TS Abutment System
Osstem Implant Co., Ltd.
Lithoblast Single Use Holmium Laser Fibers
Dawell Medical, LLC
NIDO Pedicle Screw System
Kalitec Medical
IOB Temperature Management System
Iob Medical, Inc.
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentan
Gmp Medicare Sdn. Bhd.
Paradigm System
Proprio, Inc.
Disposable Medical Nitrile Examination Gloves
Hebei Titans Hongsen Medical Technology Co., Ltd.
Assert-IQ Insertable Cardiac Monitor
ABBOTT MEDICAL
SIS System
Surgical Information Sciences, Inc.
BTL-785X
BTL Industries, Inc.
Pectus Support Bar System
Biomet Microfixation
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
Dongguan Lide Electric Appliance Co., Ltd.
Single use stone retrieval balloons
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Eminent Spine 3D Titanium Pedicle Screw System
Eminent Spine
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
Winner Medical Co., Ltd.
CoreLevee
Lutronic Corporation
Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoje
CMT Health PTE., Ltd.
Stage
Spintech, Inc.
Chemo Mouthpiece
Chemo Mouthpiece, LLC
Orthobond Mariner Pedicle Screw System
Orthobond Coporation
BoneMetrics (US)
Gleamer Sas
BIOFIRE FILMARRAY Tropical Fever Panel
Biofire Diagnostics, LLC (Biomerieux)
ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); R
Microline Surgical, Inc.
INHANCE INTACT
Depuy Ireland UC
Route 92 Medical Full Length 046 Access System
Route 92 Medical, Inc.
LANDMARK REBOA Catheter
Zien Medical Technologies, Inc.
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