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

Avanti Orthopaedics Ulnar Shortening System

Avanti Orthopaedics, Inc.

TrueBeam, TrueBeam STx, Edge, VitalBeam

Varian Medical Systems, Inc.

Biological Feedback and Stimulation System

Medlander Medical Technology, Inc.

ProSeal™ Vented Universal Vial Adaptor

Epic Medical Pte. , Ltd.

InnoVoyce Laser Fiber

Innovoyce, LLC

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

Canon Medical Systems Corporation

RADIFOCUS Torque Device

Terumo Medical Products (Hangzhou) Co., Ltd.

The InMode System with the Morpheus8 Applicators

InMode , Ltd.

BriefCase-Triage

Aidoc Medical , Ltd.

Orchid Safety Release Valve™

Linear Health Sciences, LLC

BD Alaris System with Guardrails Suite MX v12.1.2

Carefusion 303, Inc.

EnSite™ X EP System

ABBOTT MEDICAL

Besmed Bacterial Filter and HMEF

Besmed Health Business Corp

MyKnee R Pin Positioners

Medacta International S.A.

SperSort™ Sperm Sorting Chip (IPG02)

Ipreg Incorporation

Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)

Cnc Technologies

Digital Intraoral X-ray Imaging System

Iray Technology Taicang , Ltd.

Salix Coronary Plaque (V1.0.0)

Artrya Limited

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

C2dx, Inc.

5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter

Medtronic Vascular

ENTire IRE System

Entire Medical , Ltd.

Healgen URS Test Strips

Healgen Scientific,, LLC

Brainomix 360 Triage ICH

Brainomix Limited

NX01 (NX01)

Naox Technologies Sas

QuikPass Catheter

Traverse Vascular, Inc.

Iconix Speed Anchor; Iconix Speed HA+ Anchor

Riverpoint Medical

Device 300397 Putty

Geistlich Pharma AG

Blood Pressure Monitor

Guangdong Transtek Medical Electronics Co., Ltd.

ENDOGATOR™ Hybrid Irrigation Tubing

Medivators

CREOKORREKT Aligners

Creodent Prosthetics, Ltd.

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