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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.

3,665 devices · when each source was last refreshed

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

Device
MAC 7 Resting ECG Analysis System

GE Medical Systems Information Technologies, Inc

Cleared 2026-01-26

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Ascent3T Neonatal Magnetic Resonance Imaging System

Eyas Medical Imaging, Inc.

Cleared 2026-01-26

Registered with
  • US (FDA)
Tablo Hemodialysis System (PN-0008000, PN-0006000U)

Outset Medical

Cleared 2026-01-26

Registered with
  • US (FDA)
Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda

Cleared 2026-01-24

Registered with
  • US (FDA)
Holmium Laser Therapeutic Apparatus (HZ-40)

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

Cleared 2026-01-24

Registered with
  • US (FDA)
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-01-23

Registered with
  • US (FDA)
Elitone for Men

Elidah, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Life Spine, LLC

Cleared 2026-01-23

Registered with
  • US (FDA)
3.0T AIR 32CH HNA

Ge Healthcare Coils (Usa Instruments, Inc.)

Cleared 2026-01-23

Registered with
  • US (FDA)
BodyGuardian Remote Monitoring System (BGRMS v3.0)

BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

Cleared 2026-01-23

Registered with
  • US (FDA)
Pneumo Dissector Hook

ab medica sas

Cleared 2026-01-23

Registered with
  • US (FDA)
Syntex Exam Gloves

Basic Medical Technology, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
AccuContour 4.0

Manteia Technologies Co., Ltd.

Cleared 2026-01-23

Registered with
  • US (FDA)
Evidence MultiSTAT DOA Urine MultiPlex

Randox Laboratories Limited

Cleared 2026-01-23

Registered with
  • US (FDA)
MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Med-El Corp.

Cleared 2026-01-23

Registered with
  • US (FDA)
LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

SHENZHEN RAINBOW TECHNOLOGY CO., LTD.

Cleared 2026-01-23

Registered with
  • US (FDA)
QUANTIFERON®-TB Gold Plus Test

QIAGEN GmbH

Cleared 2026-01-23

Registered with
  • US (FDA)
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Point Robotics MedTech, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
New Day Skin Spray

Silk Holdings, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

Devicor Medical Products, Inc.

Cleared 2026-01-23

Registered with
  • US (FDA)
DETOUR System

Endologix, Inc.

Cleared 2026-01-22

Registered with
  • US (FDA)
Perin Health System (PHD80060-2)

Perin Health Devices, LLC

Cleared 2026-01-22

Registered with
  • US (FDA)
AV Vascular

Philips Medical Systems Nederland BV

Cleared 2026-01-22

Registered with
  • US (FDA)
SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

Lima Corporate S.P.A.

Cleared 2026-01-22

Registered with
  • US (FDA)
Pump In Style® Pro+

Medela, Inc.

Cleared 2026-01-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
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)
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)
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)
C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric

Rayner Intraocular Lenses , Ltd.

Cleared 2026-01-20

Registered with
  • US (FDA)