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
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Fehling Surgical Instruments, Inc.
Proximal Humerus Fixation System
Skeletal Dynamics, Inc.
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
PR Personal Care Laboratories
H2H Powder Free Examination Blue Glove
Ntl Innovation Co., Ltd.
Disposable Stone Retrieval Balloon Catheter
Zhejiang Soudon Medical Technology Co., Ltd.
MEDPOR Customized Implant Kit
Stryker Leibinger GmbH & Co KG
SteriTite Container System with MediTray Parts
Case Medical, Inc.
SIDDHARTH-II; IMPACT
Panacea Medical Technologies Pvt. , Ltd.
TRI-matrix® X-Force Implants
Tri Dental Implants Int. AG
BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
Bonebridge AG
ROSA® Knee System
Orthosoft Inc (D/B/A Zimmer Cas)
restor3d Pin Implants
Restor3D
RightLance Blood Lancing System
Beijing Ruicheng Medical Supplies Co., Ltd.
Apyx One Console
Apyx Medical Corporation
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis As
Hologic, Inc.
DRX-Rise Mobile X-ray System
Carestream Health
FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
Fujifilm Corporation
T-Line Hernia Mesh
Deep Blue Medical Advances, Inc.
NIRA Model 2
Dermal Photonics Corp
InActiv Blue
Fertipro NV
TENS and EMS Unit
Changsha Anxiang Medical Technology Co., Ltd.
3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M
3M Company
X-CUBE 70, X-CUBE 90
Alpinion Medical Systems Co., Ltd.
Firstar Dental Unit
Firstar Dental Company
Mobility Scooter (W3431)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
SmartChest
Milvue
Synchfix EVT
Wright Medical Technology, Inc. (Stryker Corporation)
CarbonCool® System
Global Healthcare SG Sdn. Bhd
Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
Shen Wei USA, Inc.
Latex Examination Gloves, Powder Free
Shandong Intco Medical Products Co, Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert