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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.

3,716 devices · when each source was last refreshed

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

Device
Dental Cone-beam Computed Tomography (mDX-15P Series)

Hefei Meyer Optoelectronic Technology Inc

Cleared 2026-07-23

Registered with
  • US (FDA)
FACEGYM Pro Device (HD-109)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-07-23

Registered with
  • US (FDA)
RXiBreeze PAP System (RXiBreeze 20C)

RESVENT MEDICAL TECHNOLOGY CO., LTD.

Cleared 2026-07-23

Registered with
  • US (FDA)
SENSARTM 1-Piece IOL, AAB00; TECNISTM 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00; TECNISTM 1-Piece OptiB

Johnson&Johnson Surgical Vision Inc

Cleared 2026-07-23

Registered with
  • US (FDA)
  • AU (TGA)
Perfadex Plus

Xvivo Perfusion AB

Cleared 2026-07-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
3d Cage Cervical

Fims Co., Ltd.

Cleared 2026-07-23

Registered with
  • US (FDA)
CORE 300 Digital Stethoscope

Eko Health, Inc

Cleared 2026-07-23

Registered with
  • US (FDA)
  • Canada (Health Canada)
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

Esonic Technology (Wuhan) Co., Ltd.

Cleared 2026-07-23

Registered with
  • US (FDA)
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)

Beijing Konted Medical Technology Co.,Ltd

Cleared 2026-07-23

Registered with
  • US (FDA)
ImageGrid StreamVue

CANDELIS INC.

Cleared 2026-07-23

Registered with
  • US (FDA)
  • Canada (Health Canada)
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)

Guangzhou Daxin Health Technology Co., Ltd.

Cleared 2026-07-23

Registered with
  • US (FDA)
Klassic Infection Spacer System

Total Joint Orthopedics, Inc.

Cleared 2026-07-23

Registered with
  • US (FDA)
Total Flow Medical Femoral Arterial (TFA) cannula

Total Flow Medical Limited

Cleared 2026-07-23

Registered with
  • US (FDA)
TRUE METRIX Self Monitoring Blood Glucose System

Trividia Health, Inc

Cleared 2026-07-23

Registered with
  • US (FDA)
Gepotidacin GEP 10 µg

Liofilchem S. R. L.

Cleared 2026-07-23

Registered with
  • US (FDA)
  • EU (EUDAMED)
Lacrosse NSE ALPHA Coronary Dilatation Catheter

NIPRO VASCULAR CORPORATION (formerly Goodman Co., Ltd.)

Cleared 2026-07-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
AlphaTriPart - Monopolar MIC Instruments

Gimmi GmbH

Cleared 2026-07-22

Registered with
  • US (FDA)
E3D™-C Interbody System

Evolution Spine, LLC

Cleared 2026-07-22

Registered with
  • US (FDA)
  • AU (TGA)
NanoZoomer S540MD Slide Scanner System

Hamamatsu Photonics K.K.

Cleared 2026-07-22

Registered with
  • US (FDA)
STEDI Scan Device

Stroke DX

Cleared 2026-07-22

Registered with
  • US (FDA)
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)
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)
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)