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

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.

← PrevPage 104 of 500Next →

Track 510(k) device clearances

Get notified when new devices are cleared in your category.

Set Up Free Alert