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

KLS Martin Drill-Free MMF Screw

KLS-Martin L.P.

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

Argon Medical Devices, Inc.

Balanced Knee System TriMax Porous Femoral Components

Ortho Development Corp.

ControlRad Select Model Z

Controlrad, Inc.

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Tornier, Inc.

Taperloc® Complete Hip Stem

Biomet, Inc.

SOLIUS PRO UVB Light Panel

Solius Labs, Inc.

“BioGend” Interbody Fusion System 001 Cage

Biogend Therapeutics Co., Ltd.

Zipline Access Catheter

Perfuze, Ltd.

Disposable Manual Resuscitator

Xiamen Compower Medical Tech. Co., Ltd.

Powder Free Nitrile Examination Gloves, Blue Chemotest

Careglove Global Sdn. Bhd.

SPRINT PNS System

Spr Therapeutics, Inc.

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

Steris

Uterine ElevatOR PRO with OccludOR Balloon

The O R Company Pty, Ltd.

QT ECG

QT Medical, Inc.

Neo Sculptor (OF-NEO001)

Ofan Intelligent Technology (Guangzhou) Co. , Ltd.

eXaSkin Plus

Anatomical Geometry S.L.

HemosIL Silica Clotting Time

Instrumentation Laboratory (IL) Co.

FairFix AM Adjustable Button FairFix PSP Adjustable Button

Medacta International S.A.

Progenix Select Stim

Progenix, LLC

Fibresolve (with PCCP)

Imvaria, Inc.

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

Canon Medical Systems Corporation

Electronic Thermometer (XHF2001, XHF2002)

Putian Hanjiang Huafeng Plastic Co., Ltd.

Surgical Face Mask (HNFM0103)

Shanghai Hua EN Industrial Co, Ltd.

ECHELON Oval V6.2 MRI System

Fujifilm Healthcare Corporation

Tristel Duo ULT

Tristel Solutions Limited

NightOwl

Ectosense NV

Origin™ Cemented Hip Stem

Signature Orthopaedics Pty, Ltd.

Arthrex SutureTape

Arthrex, Inc.

A-LYTE® Integrated Multisensor (IMT Na K Cl)

Siemens Healthcare Diagnostics, Inc.

← PrevPage 97 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert