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
VASSALLO GT 018 Floppy
Filmecc Co., Ltd.
Glidewell 3DP Denture Base Resin
Prismatik Dentalcraft, Inc.
The ETHICON Total Energy System
Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
B&E Korea Co., Ltd.
EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Signature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS
EmbryoSlide+ ic8 dish
Vitrolife A/S
KALA MINI 2.0 (KALA-04)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Venus BlissMAX
Venus Concept USA, Inc.
SPY Cystoscope/Hysteroscope
Stryker Endoscopy
Precice Max System and Precice Ankle Salvage System
NuVasive Specialized Orthopedics
Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily
Yung Sheng Optical Co., Ltd.
Disposable Percutaneous Nephrostomy Dilatation Kit
Shenzhen Trious Medical Technology Co., Ltd.
Osteoboost Belt
Bone Health Technologies, Inc.
inspired VHB20 Heated Humidifier
Vincent Healthcare Products Limited
Fibercure
Lumendo AG
Cemented Plus Abutment
Unidental Co., Ltd.
Surgical Gown, Reinforced Surgical Gown
Wuhan Zonsen Medical Products Co., Ltd.
3Dicom MD
Singular Health Pty, Ltd.
visio.lign color, visio.lign shield
Bredent GmbH & Co. KG
HVT 2.0
Vapotherm, Inc.
The Acumed Wrist Fixation System - 2.4mm Screws
Acumed, LLC
Pastelle
Wontech Co., Ltd.
Cerebral Autoregulation Index (CAI) Algorithm
Edwards Lifesciences
Meduloc Intramedullary Fracture Fixation (IFF) System
Meduloc, LLC
CardioPhase® hsCRP
Siemens Healthcare Diagnostic Products GmbH
MIST IC
Imagine Milling Technologies, LLC
Dynamo Spinal Cement; Salvo® Spine System
Spine Wave, Inc.
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Strea
Medtronic, Inc.
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert