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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
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)
Ion Endoluminal System (IF1000)

Intuitive Surgical, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
SwiftSight-Brain

Airs Medical, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
Santreva™-ATK Endovascular Revasculariztion Catheter

AngioSafe, Inc.

Cleared 2025-09-22

Registered with
  • US (FDA)
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

Surgical Principals, Inc.

Cleared 2025-09-22

Registered with
  • US (FDA)
Babio® Virus Transport Kit (Non-inactivating)

JINAN BABIO BIOTECHNOLOGY CO, LTD

Cleared 2025-09-22

Registered with
  • US (FDA)
IC-Flow™ Imaging System 2.0

Diagnostic Green GmbH

Cleared 2025-09-22

Registered with
  • US (FDA)
ENDOFLATOR +

Karl Storz SE & CO.KG

Cleared 2025-09-22

Registered with
  • US (FDA)
Coated hip implants

Medacta International S.A.

Cleared 2025-09-19

Registered with
  • US (FDA)
VEGA

Ibramed Equipamentos Medicos

Cleared 2025-09-19

Registered with
  • US (FDA)
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Cytocell Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
Alegria Flash ENA Screen

Zeus Scientific, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

NAKANISHI INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Sonicaid Team3

HUNTLEIGH HEALTHCARE LTD.

Cleared 2025-09-19

Registered with
  • US (FDA)
Carotid WALLSTENT Monorail Endoprosthesis

Boston Scientific Corp

Cleared 2025-09-19

Registered with
  • US (FDA)
  • AU (TGA)
IPGTFL-02

Ipg Medical Corporation

Cleared 2025-09-19

Registered with
  • US (FDA)
Portable mesh nebulizer (JM821)

Shenzhen Jermei Medical Device Technology Co,Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)
TAPESTRY Biointegrative Implant

Embody, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Bunkerhill ECG-EF

Bunkerhill Health

Cleared 2025-09-19

Registered with
  • US (FDA)
xR IVD

Tempus AI, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Single Use Suction-Evacuation Ureteral Access Sheath

Anhui Happiness Workshop Medical Instruments Co, Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
Videa Dental AI

Videahealth, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
  • UK (MHRA)
BondEase 2 Topical Skin Adhesive

Optmed, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

Olympus Medical Systems Corporation

Cleared 2025-09-19

Registered with
  • US (FDA)
Well-Root PT

Vericom Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)
  • UK (MHRA)
EQUIA LC ONE

GC AMERICA INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Purema H Hemoconcentrator - Pediatric

Medica USA, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Impact PEEK Union Nail System

Nvision Biomedical Technologies, LLC

Cleared 2025-09-19

Registered with
  • US (FDA)
UniBur

NAKANISHI INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Unscented menstrual three-piece applicator tampon

Unibeauty (Hubei) Technology Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)