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
RAIN Sheath Tibial Pedal Introducer
Cordis US Corp
Origin
Nerv Technology Inc. (D.B.A.) Fluidai Medical
Skin Air Cooling System (QALF-01)
Beijing Nubway S&T Co., Ltd.
BoneVue
Curvebeam AI / Curvebeam, LLC
Sterile High-pressure Angiographic Syringes for Single-use
Shenzhen Boon Medical Supply Co., Ltd.
Flex-Thread Ulna Intramedullary Nail System
Flower Orthopedics Corporation Dba Conventus Flower
Blood Pressure Monitor (TMB-2287-B)
Guangdong Transtek Medical Electronics Co., Ltd.
Custom Stable Rigid Gas Permeable Scleral Contact Lens
Valley Contax, Inc.
Vericor Support Catheter
Vascupatent Medical (Shenzhen) Co., Ltd.
Skin Clinic Freeze Point for Warts and Skin Tags
Cryoconcepts LP
Digital Blood Pressure Monitor WBP Series
Weony (Shenzhen) Technology Co., Ltd.
EMS/TENS Massager Device
Shenzhen Imdk Medical Technology Co., Ltd.
NAJA Gastrointestinal Catheter
Chess Medical, Inc.
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Sunray Medical Products, Inc.
Heartland Health Surgical Mask
Heartland Health Products
EnHAnce PEEK Bunion System
Nvision Biomedical Technologies
CUVIS-joint (CJ150)
Curexo, Inc.
Velora Acetabular System
Restor3D, Inc.
MedtFine Safety Lancet
Ningbo Caremed Medical Products Co., Ltd.
Neodent Implant System
Jjgc Indústria E Comércia DE Materiais Dentários S.A.
DePuy Synthes 3.5mm Intrapelvic Acetabular System
DePuy Synthes
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
Nakanishi, Inc.
Mpact 3D Metal Implants Extension DMLS Technology
Medacta International S.A.
EarliPoint System
Earlitec Diagnostics, Inc.
NeutrArt
Asset Medikal Tasarim As.
Dermablate
Asclepion Laser Technologies GmbH
Dakota ALIF Plate System
Precision Spine, Inc.
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic)
CooperVision, Inc.
TriMed Bridge Plates
TriMed, Inc.
KARL STORZ Endoscopic Accessories for Urology
Karl Storz SE & CO. KG
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