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
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
Yibin Junxin Electronics Technology Co., Ltd.
ATTIVA
Italian Engineering S.R.L.
21.3 5MP Color LCD Display UMD5-21B01
Acula Technology Corp.
Ziehm Vision RFD 3D
Ziehm Imaging GmbH
Mjolnir Pro. (Multielectrode plasma)
Shenzhen Leaflife Technology Co., Ltd.
TRUST
Rgorithm Korea
HOLO Portal Surgical Guidance System
Surgalign Spine Technologies
Elecsys HSV-2 IgG (08948887160)
Roche Diagnostics
Pulse Oximeter (WS20A)
Hunan Accurate Bio-Medical Technology Co., Ltd.
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Luliang Hongruida Health Protection Technology Co., Ltd.
Anchor Bolts as Accessories to Depth Electrodes
Ad-Tech Medical Instrument Corporation
Dental Computed Tomography X-ray System
Fussen Technology Co., Ltd.
Aspira Peritoneal Drainage System
Merit Medical Systems, Inc.
Stativ® Knotted UHMWPE Suture Anchor
Healthium Medtech Limited
FAQ (102)
Foreo, Inc.
DR Safety Syringe, Sterile Hypodermic needle for Single use
Zhuhai DR Medical Instruments Co., Ltd.
Biograph Trinion
Siemens Medical Solutions USA, Inc.
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
Jiangsu Tingsn Technology Co., Ltd.
Arthrex FiberTak Suture Anchor
Arthrex, Inc.
PeekMed web
Peek Health, S.A.
Venue Fit
GE Medical Systems Ultrasound and Primary Care Diagnostics
Rebellion; Phantom Multi-Bite Kerrison Rongeur
Morpheus AG
CORE-INJECTOR
Incore Co., Ltd.
Lithoblast Single Use Holmium Laser Fibers
Dawell Medical, LLC
3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader
3M Company
Digital C-ARM with 3D
Allengers Medical Systems Limited
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLigh
Wuhan PHOMED Technology Company , Ltd.
NextAR(TM) Spine
Medacta International S.A.
Babyleo TN500
Drägerwerk AG & Co. KGaA
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
Stryker Endoscopy
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