RecallHawk

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

Dental Electric Motor

Foshan Cicada Dental Instrument Co, Ltd.

Strut Suture; No-Tie Button

Riverpoint Medical, LLC

VitalSigns 1-Lead Holter (VSH101)

VitalSigns Technology Co., Ltd.

Disposable Nitrile Gloves

Jiangsu Shenglijie Safety Products Co., Ltd.

FORUM

Carl Zeiss Meditec, AG

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Cat

Vein 360, LLC

dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coil

Invivo Corporation

Myocene

Myocene

Navigo Workstation 2.3 (FPRMC00039)

UC-CARE , Ltd.

Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)

Sanhe Laserconn Tech Co., Ltd.

MRIdian Linac System

Viewray, Incorporated

GEM Premier 5000

Instrumentation Laboratory CO

VIDAS NEPHROCHECK

Biomérieux SA

Optimotion Implants Porous Metal-Backed Patella

Optimotion Implants, LLC

XNY Disposable Gastric Calibration Tube

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Coltolux Comfort LED Curing Light

Dent4you AG

Power Wheelchair (N5515A, N5516, N5517A, N5519)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Galileo Vertebral Body Replacement Device

Bright Spine

Disposable Medical Nitrile gloves

Guangdong Xingcan Brothers Medical Technology Co.,Ltd

TrueBeam, TrueBeam STx, Edge, VitalBeam

Varian Medical Systems, Inc.

BIS™ Advance Monitoring System

Covidien, LLC

Resonic Rapid Acoustic Pulse Device

Zeltiq Aesthetics, Inc.

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound, LLC

Ochsner Connected Inhaler Sensor

Ochsner Clinic Foundation

Limbus Contour

Limbus Ai, Inc.

Tera Harz Clear

Graphy, Inc.

Access Myoglobin

Beckman Coulter, Inc.

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

Medicrea International S.A.S. (Medtronic)

EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)

Cook Ireland, Ltd.

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

Canon Medical Systems Corporation

← PrevPage 148 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert