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
Hypertension Notification Feature (HTNF)
Apple, Inc.
Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Allmed Medical (Hubei) Protective Products Co., Ltd.
MBA Biotech Implant System
MBA Biotech Co., Ltd.
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Power wheelchair
Zhejiang Zhonglei Medical Technology Co. , Ltd.
CODA Anterior Cervical Plate System
Pioneer Surgical Technology, Inc.
1060nm laser body slimming machine
Hebei JT Medical Co., Ltd.
Arthrex Knotless FiberTak Biceps Suture Anchor
Arthrex, Inc.
Access Toxo IgM II
Beckman Coulter, Inc.
StarFormer, TightWave
Fotona D.O.O.
BRM TOOL Screws
Brm Extremities Srl
VersiHD with GuideMe software
Nxstage Medical, Inc.
Motion InBra (YM-8801) wearable breast pump
Medela, LLC
RAYSCAN a-Expert3D
Ray Co., Ltd.
dS Sentinelle Breast 16ch 3.0T Coil
Invivo Corporation (Business Trade Name: Philips)
APEX 6
Rf Innovations, Inc.
Diode laser Treatment System (K18)
Hebei Keylaser Sci-Tech Co.,Ltd
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Meditrina, Inc.
Neosoma Brain Mets
Neosoma, Inc.
ArTT Augments and Buttresses and Bone Screws
Lima Corporate S.P.A.
Insulin syringe with integrated needle DL
Dlp Medical Products, Corp.
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Shenzhen Imdk Medical Technology Co., Ltd.
SKOUT® system
Iterative Scopes, Inc.
Focus HD 43 Detector
Iray Technology Taicang , Ltd.
CereFlow V1.2
Translational Mri, LLC
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, u
Shenzhen Leqing Medical Instrument Co., Ltd.
Electric Wheelchair, Model: 9000N
Silver Fox Corporation Limited
Meriglu Topical Skin Adhesive
M/s. Meril Endo Surgery Private Limited.
Arterial Pressure Monitoring Set/Tray
Spectrum Vascular
Mako Total Knee Application
Mako Surgical Corp.
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