HaRi
Start Free→

Recently FDA-cleared medical devices

Every device we hold with a US FDA 510(k) clearance decided in the last 12 months, newest first. Each one links through to its full regulatory record.

3,686 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Tornier Perform Advanced Glenoid

Tornier, Inc

Cleared 2026-07-22

Registered with
  • US (FDA)
Anovo Surgical System (6Ne)

Momentis Surgical , Ltd.

Cleared 2026-07-22

Registered with
  • US (FDA)
PreludeSYNC Radial Compression Device

Merit Medical Systems, Inc.

Cleared 2026-07-22

Registered with
  • US (FDA)
  • UK (MHRA)
Ossiclear (Ossiclear System)

Sounduct

Cleared 2026-07-22

Registered with
  • US (FDA)
enVista® Hydrophobic Acrylic Intraocular Lens (IOL); enVista® Hydrophobic Acrylic Intraocular Lens

Bausch & Lomb Incorporated

Cleared 2026-07-22

Registered with
  • US (FDA)
Lancet

Tianjin Huahong Technology Co, Ltd

Cleared 2026-07-22

Registered with
  • US (FDA)
  • AU (TGA)
Op.n™ Spine Navigation and Robotic Guidance

Ecential Robotics

Cleared 2026-07-22

Registered with
  • US (FDA)
Lapidus Screw Kit

Relja Innovations, LLC

Cleared 2026-07-22

Registered with
  • US (FDA)
Shield

Guardant Health, Inc.

Cleared 2026-07-22

Registered with
  • US (FDA)
KARL STORZ D-Light C PDD System

Karl Storz Endoscopy-America, Inc.

Cleared 2026-07-21

Registered with
  • US (FDA)
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

O&M Halyard, Inc.

Cleared 2026-07-21

Registered with
  • US (FDA)
Assurity MRI / Endurity MRI Pacemakers

Abbott Medical

Cleared 2026-07-21

Registered with
  • US (FDA)
Medical Thulium Fiber Laser Systems (UroFiber 150Q)

Rhein Laser Technologies Co., Ltd.

Cleared 2026-07-21

Registered with
  • US (FDA)
Torosa Saline Filled Testicular Prosthesis

Coloplast Corp.

Cleared 2026-07-21

Registered with
  • US (FDA)
  • AU (TGA)
SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M

Abbott Medical

Cleared 2026-07-21

Registered with
  • US (FDA)
Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield); Pipeline™ Vantage Embolization Device wit

Micro Therapeutics Inc., d/b/a ev3 Neurovascular

Cleared 2026-07-21

Registered with
  • US (FDA)
Microny

Abbott Medical

Cleared 2026-07-21

Registered with
  • US (FDA)
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP family of CRT-Ps

Abbott Medical

Cleared 2026-07-21

Registered with
  • US (FDA)
One-Fil LC

Mediclus Co., Ltd.

Cleared 2026-07-21

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut

Hycor Biomedical, Inc.

Cleared 2026-07-21

Registered with
  • US (FDA)
Raney Clips Kit

Beijing Honghugaoxiang Science and Technology Development Co.,Ltd.

Cleared 2026-07-21

Registered with
  • US (FDA)
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Xuzhou Kernel Medical Equipment Co., Ltd.

Cleared 2026-07-21

Registered with
  • US (FDA)
OTTAVA™ Robotic Surgical System

Auris Health, Inc., part of Johnson & Johnson MedTech

Cleared 2026-07-21

Registered with
  • US (FDA)
Versalock Proximal Tibial Plating System

GM Dos Reis Industria e Comercio Ltda.

Cleared 2026-07-21

Registered with
  • US (FDA)
Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC

Medtronic Minimed

Cleared 2026-07-21

Registered with
  • US (FDA)
MENTOR MEMORYSHAPE BREAST IMPLANTS

Mentor Worldwide, LLC

Cleared 2026-07-21

Registered with
  • US (FDA)
CardIQ Suite

Ge Medical Systems Scs

Cleared 2026-07-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Enlite Sensor

Medtronic, Inc

Cleared 2026-07-21

Registered with
  • US (FDA)
ResolutionMD

ResolutionMD Inc

Cleared 2026-07-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
MENTOR™ MemoryGel™ Enhance Breast Implants

Mentor Corp.

Cleared 2026-07-21

Registered with
  • US (FDA)
Thunderbolt System

Responsive Arthroscopy, LLC

Cleared 2026-07-20

Registered with
  • US (FDA)
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

Macrolux Medical Technology Co., Ltd.

Cleared 2026-07-20

Registered with
  • US (FDA)
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips

Taiwan Surgical Corporation

Cleared 2026-07-20

Registered with
  • US (FDA)
eCoin implanted tibial stimulator

Boston Scientific Corp

Cleared 2026-07-20

Registered with
  • US (FDA)
Creep Pressure Test Update for the Nexgen LPS Bearing Knee

Zimmer Inc

Cleared 2026-07-20

Registered with
  • US (FDA)
Sleep Apnea Feature (v2.0)

Samsung Electronics Co., Ltd.

Cleared 2026-07-20

Registered with
  • US (FDA)
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

Hartalega NGC Sdn. Bhd.

Cleared 2026-07-20

Registered with
  • US (FDA)
ENDOSCOPE HOLDER (182214)

AKTORmed GmbH

Cleared 2026-07-20

Registered with
  • US (FDA)
Hi-D Imaging 4TAVR

Hi-D Imaging AG

Cleared 2026-07-20

Registered with
  • US (FDA)
Dental Zirconia Blank & Coloring Liquid

Hunan Qinghao Puzhong Technology Co., Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
ZEISS CLINIC 360

Carl Zeiss Meditec AG

Cleared 2026-07-17

Registered with
  • US (FDA)
Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM

Stryker Spine, LLC

Cleared 2026-07-17

Registered with
  • US (FDA)
Natural Cycles

Natural Cycles Nordic AB

Cleared 2026-07-17

Registered with
  • US (FDA)
LED LCD Monitor (OEV-271H)

Lg Electronics

Cleared 2026-07-17

Registered with
  • US (FDA)
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Biofire Defense, LLC

Cleared 2026-07-17

Registered with
  • US (FDA)
SportSuite Vision Software

Stryker Endoscopy

Cleared 2026-07-17

Registered with
  • US (FDA)
Catalyft PL Expandable Interbody System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-07-17

Registered with
  • US (FDA)
Drivewire 35 Guidewire

Rapid-Medical , Ltd.

Cleared 2026-07-17

Registered with
  • US (FDA)
Cubresa BrainPET

Cubresa, Inc.

Cleared 2026-07-17

Registered with
  • US (FDA)
Virasight

Virasoft Corporation

Cleared 2026-07-17

Registered with
  • US (FDA)