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
Disposable Surgical Mask (Model: YYKZ-01)
Jiaxing Amazing Travel-Ware Co., Ltd.
Manual Wheelchair (W45)
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
Winner Medical Co., Ltd.
Zamenix P
Roen Surgical, Inc.
AI Platform 2.2 (AIP002)
Exo Imaging
Suture Wing
Osteonic Co., Ltd.
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Chongqing Rob Linka Science and Technology Co., Ltd.
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
Shanghai AnQing Medical Instrument Co., Ltd.
Biolox® Delta Revision heads
Limacorporate
iRelieve Microcurrent Pain Relief System
Fast Track Technologies, Inc.
The Trust
Genoss Co., Ltd.
HRSpheres Narrow-Size Embolic Microspheres
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Surcam Dental Implant System
Surcam Medical Devices and Developments, Ltd.
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAG
HC Biologics, LLC
neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.
SimpleSENSE Platform
Nanowear, Inc.
Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
Black Pearl Nitrile Examination Glove
Ug Global Resources Sdn. Bhd.
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
Zibo Kaiyue Mould Technology Co., Ltd.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
Becton, Dickinson and Company
14F Duo-Flow® Side X Side Double Lumen Catheter
Medical Components, Inc.
Iconix Knotless Anchor
Riverpoint Medical
Surgical Face Mask (Non-sterile)
Hubei Kimsoul Industrial Co., Ltd.
ELITONE Urge Urinary Incontinence Device
Elidah, Inc.
JO Coconut Hybrid Cooling Personal Lubricant
CC Wellness, LLC
BEAR 2 Body
Foreo, Inc.
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
Faceheart Corp.
CardIQ Suite
GE Medical Systems SCS
Motivista (CT-155)
Click Therapeutics, Inc.
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Sysmex America, Inc.
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