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
Electric breast pump (model: M5)
Shenzhen Lutejiacheng Technology Co., Ltd.
BD Phoenix Automated Microbiology System
Becton, Dickinson and Company
UNITY Sacroiliac Joint Fixation System
Dio Medical Corporation
Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
Imperative Care, Inc.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Pla
I.T.S. GmbH
FlowSaver Blood Filter
Inari Medical
DESS Dental Implants
Terrats Medical SL
EvoEndo Single-Use Endoscopy System
EvoEndo, Inc.
Superior Hair Remover
Guangzhou Haoxingwan Technology Co., Ltd.
SPIFE A1AT kit
Helena Laboratories, Corp.
Essilor® Stellest®
Essilor Of America, Inc.
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extr
Xtrallux, LLC
SIGNA Sprint Select
Ge Medical Systems, LLC
Arthrex Self-Punching PushLock Suture Anchor
Arthrex, Inc.
Invictus Spinal Fixation System
Alphatec Spine, Inc.
Powder Free Blue Nitrile Examination Glove
S&S Glove Corporation
ensoETM
Advanced Cooling Therapy, Inc. D/B/A Attune Medical
Sunrise
Sunrise SA
Mariner RDX System
SeaSpine Orthopedics Corporation
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
Yadu Medical (Henan) Co., Ltd.
Modular Rotating Hinge Knee Systems and Compatible Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
SoundBite® Crossing System XS Peripheral
Soundbite Medical Solutions, Inc.
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Pol
Safepath Medical, Inc.
SofWave System
Sofwave Medical, Ltd.
Argos Infinity (Rev. 1.0)
Retia Medical Systems, Inc.
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Wuhan Guangdun Technology Co.,Ltd..
Ai Ray Dental X-Ray Device
Guilin Woodpecker Medical Instrument Co., Ltd.
Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
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