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
Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (2
Kirwan Surgical Products, LLC
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/m
Belmont Medical Technologies
Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.
Huma RPM (RPM)
Medopad, Inc.
INFRARED BODY THERMOMETER (Model: YK-001)
Longnan Renzhong Medical Equipment Co., Ltd.
DenMat Bulk Fill Composite
Den-Mat Holdings, LLC
8ch Wrist Coil
Shenzhen RF Tech Co., Ltd.
Straumann CARES Visual and Nova Dental CAD
Institut Straumann AG
WasherCap Mini Fixation System (Model 45)
Abanza Tecnomed S.L
Bladeless Trocar; Bladed Trocar; Hasson Trocar
Advamedix, GmbH
KNH Surgical Face Mask
Knh Surgical Face Mask
INNOVANCE VWF Ac
Siemens Healthcare Diagnostics Products GmbH
MolecuLightDX
MolecuLight, Inc.
Dentis s-Clean Abutment Mini
Dentis Co., Ltd.
D²RS and D²RS 9090
Stephanix
Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
Covidien
Kerecis Oral
Kerecis
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
Sonova AG
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Artivion, Inc.
Face Patches (MT-12MA, MT-12MC)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Infinity Gateway Suite
Draeger Medical Systems, Inc.
MirrorMe3D Modeling System
Mirrorme3D, LLC
Inbentus Versatile
Iconic Solutions by Murcia, SL
PrimeTaper EV Dental Implant
Dentsply Sirona, Inc.
Xpert® FII & FV
Cepheid
ArthroFree Wireless Surgical Camera System
Lazurite Holdings, LLC
Trevo NXT ProVue Retriever
Stryker Neurovascular
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations, LLC
BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx
Vivachek Biotech (Hangzhou) Co., Ltd.
VVR Generator system
Starmed Co., Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert