510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
3,400 total clearances
Y-Knotless Flex Anchors
Conmed Corporation
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
Beijing Sano Laser S&T Development Co.,Ltd
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (26
Drägerwerk AG & Co. KGaA
BACK 4
Swims America Corp
Arthrex Virtual Implant Positioning (VIP) System
Arthrex, Inc.
Simplexa COVID-19 Direct
Diasorin Molecular, LLC
CEREGLIDE 92 Intermediate Catheter
Cerenovus, Inc.
Aulisa Temperature Module (TM0002)
Taiwan Aulisa Medical Devices Technologies, Inc.
Disposable Biopsy Needle
Carbon (Shenzhen) Medical Device Co., Ltd.
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro,
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical Technology Co., Ltd.
Radiance V5
Gmv Soluciones Globales Internet S.A.U.
DentMix VPS Impression Material
Innovative Product Brands, Inc.
EVA15 insufflator
Palliare , Ltd.
Progrip Self-Gripping Polypropylene Mesh
Sofradim Production
CustomSurg OrthoPlanner
Customsurg AG
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Medline Industries, Inc.
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
Lightstone Medical Products (Ningbo) Co, Ltd.
Endophys Blood Pressure Monitor model BPM-30
Endophys Technologies, LLC
QP-Prostate® CAD
Quibim S.L.
EMS Sculpt Machine
Shandong Huamei Technology Co., Ltd.
iRAD
Claritas Healthtech Pte, Ltd.
Extended Reservoir
Medtronic Minimed, Inc.
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Xuzhou Kernel Medical Equipment Co., Ltd.
Fixone Biocomposite Anchor
Aju Pharm Co., Ltd.
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SP
Solco Biomedical Copany India Private Limited
SurfRider 13 Microcatheter
Kaneka Americas Holding, Inc.
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LIAISON PLEX Gram-Negative Blood Culture Assay
Luminex Corporation
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