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
STIMPOD NMS460 Nerve Stimulator
Algiamed Technologies USA, Inc.
OxyGo Portable Oxygen Concentrator (1400-7000)
Mv Life, LLC
ARIX Femur Nail System
Jeil Medical Corporation
syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
CellFX System
Pulse Biosciences, Inc.
restor3d Kinos Axiom Total Ankle System
Restor3D, Inc.
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
INTEROJO, Inc.
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultra
Samsung Medison Co., Ltd.
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wi
Merit Medical Ireland, Ltd.
Xpert® SA Nasal Complete
Cepheid®
Surgical Mask
Remade USA, LLC
Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
Guangdong Golden Leaves Technology Development Co., Ltd.
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Hartalega NGC Sdn. Bhd.
Vacuum Pump (Model: AD-VPUM-500)
Sheng Sheng Yi (Beijing) Technology Company Limited
Biodegradable Medical surgical mask
Guangdong Kingfa Sci. & Tech.Co., Ltd.
Precision S 4K Sinuscope
Stryker Endoscopy
ECHELON ENDOPATH Staple Line Reinforcement
Ethicon Endo-Surgery, LLC
CURIS II RF Generator (REF 360100-05)
Sutter Medizintechnik GmbH
HeartBuds Electronic Stethoscope
Heartbuds, LLC
aprevo® TLIF-C Articulating System
Carlsmed
Cryo Sport 2.0 (AVA 501)
Avanutri Equipamentos DE Saúde
Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses
Paragon Vision Sciences, Inc.
EyeCTester
Neuro-Eye Diagnostic Systems, LLC
Endoscopic Video Image Processor, Single-Use Video Hysteroscope
Guangzhou Red Pine Medical Instrument Co., Ltd.
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Integra Lifesciences Production Corporation
Promisemed Safety Huber Needles
Promisemed Hangzhou Meditech Co., Ltd.
BriefCase-Triage
Aidoc Medical , Ltd.
SONIK MONARK 100
Neuro Spinal Innovation, Inc.
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
Sri Trang Gloves (Thailand) Public Company Limited
Lux HD 2530 detector (Lux HD 2530)
Iray Imaging Technology (Haining) Limited
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