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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.

3,400 devices · when each source was last refreshed

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

Device
AI-Rad Companion Brain MR

Siemens Healthcare GmbH

Cleared 2026-01-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Straumann Variobase Abutments XC for Bridge/Bar

Institut Straumann AG

Cleared 2026-01-22

Registered with
  • US (FDA)
Genie MAX Large Bore Introducer Sheath

Cultiv8 1, LLC

Cleared 2026-01-22

Registered with
  • US (FDA)
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Astura Medical

Cleared 2026-01-22

Registered with
  • US (FDA)
Device 104 Particulate

Geistlich-Pharma

Cleared 2026-01-22

Registered with
  • US (FDA)
PhenoMATRIX

Copan WASP Srl

Cleared 2026-01-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Getinge GSS67N Series Steam Sterilizer

Maquet GmbH (A Getinge Group Company)

Cleared 2026-01-22

Registered with
  • US (FDA)
IPDmilled Blanks

Implant Protesis Dental 2004, S.L.

Cleared 2026-01-22

Registered with
  • US (FDA)
Arthrex Variable Angle (VA) Proximal Tibia Plating System

Arthrex, Inc.

Cleared 2026-01-21

Registered with
  • US (FDA)
Boston Pico755

Boston Aesthetics, Inc.

Cleared 2026-01-21

Registered with
  • US (FDA)
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

Merit Medical Ireland, Ltd.

Cleared 2026-01-21

Registered with
  • US (FDA)
INFINITY™ OCT System

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-01-21

Registered with
  • US (FDA)
Halcyon, Ethos Radiotherapy System (5.0)

Varian Medical Systems inc

Cleared 2026-01-21

Registered with
  • US (FDA)
Affirm 400

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)

Cleared 2026-01-21

Registered with
  • US (FDA)
LumiCera

Hangzhou Shining3D Dental Technology Co., Ltd.

Cleared 2026-01-21

Registered with
  • US (FDA)
RoVo Mechanical Thrombectomy System

Verge Medical, Inc.

Cleared 2026-01-21

Registered with
  • US (FDA)
Tula Tube Delivery System (TDS)

Tusker Medical

Cleared 2026-01-21

Registered with
  • US (FDA)
Nova Max Creat eGFR Monitoring System

Nova Biomedical Corp.

Cleared 2026-01-21

Registered with
  • US (FDA)
Excelsior System

Blue Ocean Global

Cleared 2026-01-20

Registered with
  • US (FDA)
uCT 780 with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2026-01-20

Registered with
  • US (FDA)
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

Carestream Health, Inc.

Cleared 2026-01-20

Registered with
  • US (FDA)
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)

Scivita Medical Technology Co, Ltd

Cleared 2026-01-20

Registered with
  • US (FDA)
Clearview Intracoronary Shunts

Medtronic, Inc

Cleared 2026-01-20

Registered with
  • US (FDA)
Rusch SoftSimplastic Foley Catheters

Teleflex Medical Sdn Bhd

Cleared 2026-01-20

Registered with
  • US (FDA)
VariFuse Adjustable Infusion Catheter

Argon Medical Devices, Inc.

Cleared 2026-01-20

Registered with
  • US (FDA)
Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

Cooper Surgical

Cleared 2026-01-20

Registered with
  • US (FDA)
Rayner C-flex 570, C-flex Aspheric 970, 600 Aspheric Intraocular lenses, RayOne Aspheric RA0600, RayOne Spheric RAO100 a

Rayner Intraocular Lenses , Ltd.

Cleared 2026-01-20

Registered with
  • US (FDA)
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation

Cleared 2026-01-20

Registered with
  • US (FDA)
Baylis Connector Cable

BAYLIS MEDICAL TECHNOLOGIES INC.

Cleared 2026-01-18

Registered with
  • US (FDA)
  • Canada (Health Canada)
CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Biosense Webster, Inc.

Cleared 2026-01-18

Registered with
  • US (FDA)
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Medtronic, Ireland

Cleared 2026-01-17

Registered with
  • US (FDA)
NeuroSpan Bridge

Auxilium Biotechnologies, Inc.

Cleared 2026-01-17

Registered with
  • US (FDA)
Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

Medtronic, Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
Xpert GI Panel

Cepheid Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
  • UK (MHRA)
Imagine® Enterprise Suite

Softlink International, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
FL-10000U Respiratory Humidifier

Flexicare Medical Ltd

Cleared 2026-01-16

Registered with
  • US (FDA)
VITAL Tubing Sets for Hemodialysis

Vital Healthcare Sdn Bhd

Cleared 2026-01-16

Registered with
  • US (FDA)
CoolTone

Zimmer Medizinsysteme GmbH

Cleared 2026-01-16

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

Hycor Biomedical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
Eyer 2

Phelcom Technologies

Cleared 2026-01-16

Registered with
  • US (FDA)
Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

Curiteva, LLC

Cleared 2026-01-16

Registered with
  • US (FDA)
SOLIUS PRO UVB Light Panel

Solius Labs, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
actiTENS mini

SUBLIMED

Cleared 2026-01-16

Registered with
  • US (FDA)
  • EU (EUDAMED)
MY01 Continuous Compartmental Pressure Monitor

MY01, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Azurion R3.1

Philips Medical Systems, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

Intuitive Surgical, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
SeptAlign

Spirair, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)
LZI Buprenorphine II Enzyme Immunoassay

Lin-Zhi International Inc

Cleared 2026-01-16

Registered with
  • US (FDA)
qXR-Detect

Qure.Ai Technologies

Cleared 2026-01-16

Registered with
  • US (FDA)
Natrelle 133S Tissue Expanders

AbbVie, Inc.

Cleared 2026-01-16

Registered with
  • US (FDA)