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
HP-OCT (HP-OCT)
Cylite Pty. , Ltd.
Klockner Kits
SOADCO, S.L.
Electric Wheelchair (E201)
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
OnPoint Augmented Reality Spine System
Onpoint Surgical, Inc.
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
Mindset Medical, Inc.
Dual Stage Venous Cannulae
Sorin Group Italia S.R.L.
NeuroQuant
Cortechs Labs, Inc.
INNOVISION-P5
Dk Medical Systems Co., Ltd.
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
Galvanize Therapeutics, Inc.
UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205
Karl Storz SE & CO. KG
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
Sorin Group Italia S.R.L.
VS-370CF, VS-370CT
VISION MEDICAL Co., Ltd.
Sterile Syringe with Fixed Safety Needle for Single Use
Gemtier Medical (Shanghai), Inc.
NITRO Interbody Fusion Cage System Family
Ctl Medical Corporation
EaseVRx
Appliedvr, Inc.
MOLLI 2
Molli Surgical, Inc.
JuniOrtho Plating System
Orthofix Srl
XC11 ICE System, USA
Yorlabs, Inc.
Surgical Face Mask (Non-sterile)
Xiantao Junhui Plastic Products Co., Ltd.
Power wheelchair (ZS-EW8026)
Ningbo Zhishan Medical Technology Co., Ltd.
HS Fiber Sutures
Riverpoint Medical
Platform treatment system
Shanghai Apolo Medical Technology Co., Ltd.
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCa
Vitrolife Sweden AB
MilkMate Breast Pump
Milkmate Products, Inc.
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
Zhejiang Curaway Medical Technology Co., Ltd.
EMERGE Anterior Cervical Plate System
Evolution Spine
EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
Medos-International Sarl
FLEXI-PORT Power Injectable Implantable Port
Portal Access, Inc.
Goody Gloves, Wincare, TBG Gloves
Thai Rubber Gloves Co., Ltd.
Electric wheelchair
Foshan Dahao Medical Technology Co., Ltd.
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