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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.

3,664 devices · when each source was last refreshed

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

Device
Magnetic Surgical System

Levita Magnetics International Corp

Cleared 2025-09-26

Registered with
  • US (FDA)
Planmed XFI

Planmed OY

Cleared 2025-09-26

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Thulium Laser System (Deluxlase)

Nanjing Bestview Laser S&T Co., Ltd.

Cleared 2025-09-26

Registered with
  • US (FDA)
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Linshom Medical, Inc.

Cleared 2025-09-26

Registered with
  • US (FDA)
VitalStream ART Connect; VitalStream-Hemo

Caretaker Medical, LLC

Cleared 2025-09-26

Registered with
  • US (FDA)
Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

Canon Medical Systems Corporation

Cleared 2025-09-26

Registered with
  • US (FDA)
Auxano® Wedge Fixation System

Auxano Medical, LLC

Cleared 2025-09-25

Registered with
  • US (FDA)
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced

Covidien

Cleared 2025-09-25

Registered with
  • US (FDA)
Endeavor™ Stand-Alone Cervical IBF System

INNOVASIS, INC.

Cleared 2025-09-25

Registered with
  • US (FDA)
Panther Fusion GI Expanded Bacterial Assay

Hologic Inc

Cleared 2025-09-25

Registered with
  • US (FDA)
  • EU (EUDAMED)
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

THERMO FISHER SCIENTIFIC INC.

Cleared 2025-09-25

Registered with
  • US (FDA)
Panther Fusion GI Bacterial Assay

Hologic Inc

Cleared 2025-09-25

Registered with
  • US (FDA)
  • EU (EUDAMED)
Steripath® Flow™ Blood Collection System

Magnolia Medical Technologies, Inc.

Cleared 2025-09-25

Registered with
  • US (FDA)
Single-Use Biopsy Valve (MAJ-1555)

Olympus Medical Systems Corporation

Cleared 2025-09-25

Registered with
  • US (FDA)
Essilor® Stellest®

Essilor of America, Inc.

Cleared 2025-09-25

Registered with
  • US (FDA)
Pulse oximeter

Shanghai Berry Electronic Tech Co., Ltd.

Cleared 2025-09-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Stem Extension Line (U2 Total Knee System—PSA Type)

United Orthopedic Corporation

Cleared 2025-09-25

Registered with
  • US (FDA)
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer

Stryker Instruments

Cleared 2025-09-25

Registered with
  • US (FDA)
JDEvolution Plus L and JDEvolution Plus LE

JDentalCare Srl

Cleared 2025-09-25

Registered with
  • US (FDA)
EMBOTRAP III Revascularization Device

NEURAVI LIMITED

Cleared 2025-09-25

Registered with
  • US (FDA)
  • Canada (Health Canada)
Hi bebe super (BT-150B)

Bistos Co., Ltd.

Cleared 2025-09-25

Registered with
  • US (FDA)
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

Yung Sheng Optical Co, Ltd

Cleared 2025-09-25

Registered with
  • US (FDA)
uMR 680

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2025-09-25

Registered with
  • US (FDA)
  • AU (TGA)
Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)

Wuhan Dimed Laser Technology Co., Ltd.

Cleared 2025-09-25

Registered with
  • US (FDA)
Brain WMH

Quantib B.V.

Cleared 2025-09-25

Registered with
  • US (FDA)
Alinity m HCV

Abbott Molecular, Inc.

Cleared 2025-09-25

Registered with
  • US (FDA)
  • AU (TGA)
Root canal repair materials (nRoot BP)

Enpuno Biotechnology Co., Ltd.

Cleared 2025-09-25

Registered with
  • US (FDA)
Resitu Slider 09 (RESL09)

Resitu Medical AB

Cleared 2025-09-24

Registered with
  • US (FDA)
Digital X-Ray DentiMax Pro Imaging System

DENTIMAX

Cleared 2025-09-24

Registered with
  • US (FDA)
Celerity 20 HP Biological Indicator

STERIS SAS

Cleared 2025-09-24

Registered with
  • US (FDA)
uWS-Angio Pro

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2025-09-24

Registered with
  • US (FDA)
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

Alma Lasers , Ltd.

Cleared 2025-09-24

Registered with
  • US (FDA)
LenSx Laser System (8065000944)

Alcon Laboratories

Cleared 2025-09-24

Registered with
  • US (FDA)
MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)

Imaxeon Pty, Ltd.

Cleared 2025-09-24

Registered with
  • US (FDA)
Retraxil

Kulzer, LLC

Cleared 2025-09-24

Registered with
  • US (FDA)
  • UK (MHRA)
ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)

Endorobotics Co., Ltd.

Cleared 2025-09-24

Registered with
  • US (FDA)
t:slim X2 insulin pump with interoperable technology

Tandem Diabetes Care, Inc.

Cleared 2025-09-24

Registered with
  • US (FDA)
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

Boston Scientific Corp

Cleared 2025-09-24

Registered with
  • US (FDA)
Pounce(TM) Sheath

Surmodics,Inc.

Cleared 2025-09-24

Registered with
  • US (FDA)
ProVee Video Processing Unit (PV-003)

Proverum Limited

Cleared 2025-09-24

Registered with
  • US (FDA)
Polyvinyl Alcohol Embolic Microspheres

Canyon Medical, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
Edwards MC3 Tricuspid annuloplasty ring (4900)

Edwards Lifesciences, LLC

Cleared 2025-09-23

Registered with
  • US (FDA)
Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated

Cleared 2025-09-23

Registered with
  • US (FDA)
Rapid Aortic Measurements

Ischemaview, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

Hangzhou Shining3D Dental Technology Co., Ltd.

Cleared 2025-09-23

Registered with
  • US (FDA)
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

M/s. Meril Endo Surgery Private Limited.

Cleared 2025-09-23

Registered with
  • US (FDA)
Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

Olympus Winter &Ibe GmbH

Cleared 2025-09-23

Registered with
  • US (FDA)
Zenflow Spring Scope

Zenflow, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
Himaging Bronchscope System

Himaging Technology (Shanghai) Co., Ltd.

Cleared 2025-09-23

Registered with
  • US (FDA)
Luminance Red Cold Sore Device (TN1927G)

Luminance Medical Ventures, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)