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
Powder Free Nitrile Gloves
St Future International Limited
Digital Prism Correction Feature (DPCF)
Apple, Inc.
Ambu® aScope Colon; Ambu® aBox 2
Ambu A/S
CleanSeal Advanced Bipolar Vessel Sealer Maryland
Conmed Corporation
DOLORCLAST Focused Shock Waves
E.M.S Electro Medical Systems S.A
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP
Shenzhen Root Innovation Technology Co., Ltd.
Cala kIQ
Cala Health, Inc.
FUJIFILM Endoscope Model EB-710XT
FUJIFILM Healthcare Americas Corporation
Infrascanner
Infrascan, Inc.
DeepRESP
Nox Medical Ehf
Fule Metallic Lockable Intramedullary Nail Systems
Beijing Fule Science & Technology Development Co., Ltd.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd.
Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Flui
Owens & Minor (O&M) Halyard, Inc.
SnugFit All-Suture Anchor extension
Medacta International S.A.
Revolve Surgical System
Revolve Surgical, Inc.
SURGIVISIO Device
Ecential Robotics
Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
Shenzhen Best Electronics Co., Ltd.
Micromate Navi+
Isys Medizintechnik GmbH
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon P
Terragene S.A.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc
Zoll Circulation, Inc.
AccuCTP
ArteryFlow Technology Co., Ltd.
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
Uweport, LLC
Identity Shoulder System
Zimmer, Inc.
LiNA OperaScope Needle
Lina Medical Aps
Diacore
ShenB Co., Ltd.
BD Insyte IV Catheter
Becton Dickinson Infusion Therapy Systems, Inc.
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
Guilin Woodpecker Medical Instrument Co., Ltd.
FAQ (LED Panel); FAQ (Dual LED Panel)
Foreo, Inc.
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Urethral Warming Catheter Kit
Varian Medical Systems, Inc.
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