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
EnSite X EP System
ABBOTT MEDICAL
Cochlear Osia System
Cochlear Americas
NomadAir PMU810
Neurotronics, Inc.
SIGNA Victor
Ge Healthcare (Tianjin) Company Limited
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
Togo Medikit Co., Ltd.
NextDent Jet Denture Base; NextDent Jet Denture Teeth
Vertex-Dental B.V.
14HQ901G-B
Lg Electronics.Inc
ALGO 7i
Path Medical GmbH
Disposable Vinyl Examination Gloves
Jiangxi Handspro Products Solutions Co., Ltd.
Suture-TOOL System
Suturion AB
MiniLoad Syringe
Ocuject, LLC
SeptiCyte RAPID
Immunexpress, Inc.
Gelsoft Plus Vascular Prostheses
Vascutek, Ltd.
Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd.
14F iSLEEVE Introducer Set
Boston Scientific Corporation
EnSite X EP System
ABBOTT MEDICAL
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
Bausch and Lomb, Incorporated
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi
Chemtron Biotech, Inc.
Nitrile Examination Gloves
Hsk Medical Apparatus Foshan China Co., Ltd.
Neodent Implant System - Zirconia Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A.
The ETHICON Total Energy System
Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)
V-soft Line Barbed Surgical Suture (Various)
Feeltech Co., Ltd.
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
Abbott Molecular
BD Vacutainer® Fluoride Blood Collection Tubes
Becton, Dickinson and Company
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fen
O&M Halyard, Inc.
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement
Imaxeon Pty, Ltd.
Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
Henan Yadu Level 4 Surgical Gowns (Reinforced)
Yadu Medical (Henan) Co., Ltd.
C-beam
Pulmera, Inc.
Flow-Nail
Flow-Fx, LLC
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