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
Philips Incisive CT on Trailer
Philips Healthcare (Suzhou) Co., Ltd.
Affirm 800
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
ETHICON, Inc.
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
Micro-Energy Medical Technology Co., Ltd.
SternalPlate Expansion
Stryker Leibinger GmbH & Co KG
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Jiangsu Jichun Medical Devices Co., Ltd.
Difiney Advanced Anti Snoring Device 4.0
Fissiontech, LLC
Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
DEKA SMARTPERIO
El.En Electronic Engineering Spa
Disposable Veress Needles
Hangzhou Kangji Medical Instrument Co., Ltd.
ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, Inc.
LED Lip Perfector, model: ZC-05
Light Tree Ventures Europe B.V.
TLAB® Transvenous Liver Biopsy System (TF-18C)
Argon Medical Devices, Inc.
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
Disposable hemoclip
Beijing Zksk Technology Co., Ltd.
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat
Ever Global (Vietnam) Enterprise Corporation
CORE 500 Digital Stethoscope
Eko Devices, Inc.
eQUANT System
Avails Medical, Inc.
SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
MOLLI 2 System
Molli Surgical, Inc.
Yomi Robotic System with YomiPlan Go
Neocis, Inc.
inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidif
Vincent Healthcare Products Limited
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
Hangzhou SHINING3D Dental Technology Co., Ltd.
CATHTONG II PICC Catheter
L&Z Us, Inc.
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
23AndMe, Inc.
Lucas Plus
Amt Engineering Co., Ltd.
ELID (Endoscopic Less Invasive Decompression) System
Lesspine Innovations
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
Stryker
A1417MCW/A1717MCW/F1417MCW
H&abyz Co., Ltd.
Resolve Modular Revision Hip Stem
United Orthopedic Corporation
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