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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.

3,392 devices · when each source was last refreshed

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

Device
WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

WONDFO USA CO., LTD.

Cleared 2025-08-20

Registered with
  • US (FDA)
T1D1

Comerge AG

Cleared 2025-08-20

Registered with
  • US (FDA)
Methinks CTA Stroke

Methinks Software SL

Cleared 2025-08-20

Registered with
  • US (FDA)
Remanufactured EndoWrist Cobra Grasper (420190)

Rebotix

Cleared 2025-08-20

Registered with
  • US (FDA)
IPD Dental Implant Abutments

Implant Protesis Dental 2004, S.L.

Cleared 2025-08-20

Registered with
  • US (FDA)
Wearable Breast Pump (Model W6)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2025-08-20

Registered with
  • US (FDA)
Distal Xtremities System

Trimed Pvt Ltd

Cleared 2025-08-20

Registered with
  • US (FDA)
EndoFix™Tissue Fixation System

Softac Medical Technologies

Cleared 2025-08-20

Registered with
  • US (FDA)
Surpass Evolve Flow Diverter Systems

STRYKER NEUROVASCULAR

Cleared 2025-08-20

Registered with
  • US (FDA)
  • AU (TGA)
Salix Coronary Plaque (V1.0.0)

Artrya Limited

Cleared 2025-08-20

Registered with
  • US (FDA)
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

Liofilchem S. R. L.

Cleared 2025-08-20

Registered with
  • US (FDA)
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

Beckman Coulter, Inc.

Cleared 2025-08-20

Registered with
  • US (FDA)
T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System

Stryker Corp.

Cleared 2025-08-20

Registered with
  • US (FDA)
Delphi-MD System

Quantalx Neuroscience

Cleared 2025-08-20

Registered with
  • US (FDA)
Remanufactured EndoWrist Tenaculum Forceps (420207)

Rebotix

Cleared 2025-08-19

Registered with
  • US (FDA)
Remanufactured EndoWrist Cadiere Forceps (420049)

Rebotix

Cleared 2025-08-19

Registered with
  • US (FDA)
Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Agnes Medical Co., Ltd.

Cleared 2025-08-19

Registered with
  • US (FDA)
Remanufactured EndoWrist Long Tip Forceps (420048)

Rebotix

Cleared 2025-08-19

Registered with
  • US (FDA)
OSSIOfiber® Interference Screw

OSSIO , Ltd.

Cleared 2025-08-19

Registered with
  • US (FDA)
Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Venclose, Inc.

Cleared 2025-08-19

Registered with
  • US (FDA)
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

Harps Europe Manufacturing GmbH

Cleared 2025-08-19

Registered with
  • US (FDA)
ANTHEM™ Fracture System

Globus Medical, Inc.

Cleared 2025-08-18

Registered with
  • US (FDA)
Evolution Spine Navigation Instruments

Evolution Spine, LLC

Cleared 2025-08-18

Registered with
  • US (FDA)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

O&M Halyard, Inc.

Cleared 2025-08-18

Registered with
  • US (FDA)
Neodent Implant System - Zirconia Implant System

Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Cleared 2025-08-18

Registered with
  • US (FDA)
PnueAira (PNCU-01)

Biotab, LLC

Cleared 2025-08-18

Registered with
  • US (FDA)
OsteoCentric® UnifiMI® TCS Plating System

Osteocentric Technologies

Cleared 2025-08-16

Registered with
  • US (FDA)
VEA Align; spineEOS

Eos Imaging

Cleared 2025-08-15

Registered with
  • US (FDA)
Helios Dermal Scaffold

Helios Biomedical, Inc.

Cleared 2025-08-15

Registered with
  • US (FDA)
Idylla CDx MSI Test

Biocartis Us, Inc.

Cleared 2025-08-15

Registered with
  • US (FDA)
MMR IHC Panel pharmDx (Dako Omnis)

Agilent Technologies, Inc.

Cleared 2025-08-15

Registered with
  • US (FDA)
FEATHER 01 02 03 04 (Model:01)

Heat IN A Click, LLC

Cleared 2025-08-15

Registered with
  • US (FDA)
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

Beckman Coulter, Inc.

Cleared 2025-08-15

Registered with
  • US (FDA)
PHAROS

Brightonix Imaging

Cleared 2025-08-15

Registered with
  • US (FDA)
Zio® monitor (DFG0001)

iRhythm Technologies, Inc.

Cleared 2025-08-15

Registered with
  • US (FDA)
CHLOE BLAST

Fairtility Ltd

Cleared 2025-08-15

Registered with
  • US (FDA)
JMS CAVEO A.V. Fistula Needle Set

Jms North America Corp.

Cleared 2025-08-15

Registered with
  • US (FDA)
AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

Assure Tech. Co., Ltd.

Cleared 2025-08-15

Registered with
  • US (FDA)
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

Healgen Scientific, LLC

Cleared 2025-08-15

Registered with
  • US (FDA)
Dunamis Screw and Suture Locking System

Dunamis Medical, LLC

Cleared 2025-08-15

Registered with
  • US (FDA)
CP Relief Wand Rx - TENS/NMES

N & C Holdings, LLC

Cleared 2025-08-15

Registered with
  • US (FDA)
Persona Partial Knee

Zimmer Biomet

Cleared 2025-08-15

Registered with
  • US (FDA)
Atlas Spine Project X Expandable Posterior Lumbar Interbody System

Atlas Spine, LLC

Cleared 2025-08-15

Registered with
  • US (FDA)
Senza Spiral Cord Stimulation (SCS) System

Nevro Corporation

Cleared 2025-08-15

Registered with
  • US (FDA)
Nerveblox

Smart Alfa Teknoloji San. VE Tic. A.S.

Cleared 2025-08-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
OneRF Trigeminal Nerve Radiofrequency Probes

Neuroone Medical Technologies Corp.

Cleared 2025-08-15

Registered with
  • US (FDA)
WinForth (LM-E470KA)

SHENZHEN LEAFLIFE TECHNOLOGY CO., LTD.

Cleared 2025-08-14

Registered with
  • US (FDA)
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC

ALLERGAN

Cleared 2025-08-14

Registered with
  • US (FDA)
Stitch Cerclage – Suture Tapes

GM Dos Reis Industria e Comercio Ltda.

Cleared 2025-08-14

Registered with
  • US (FDA)
3nethra neo HD FA; 3nethra neo HD

Forus Health Pvt Ltd

Cleared 2025-08-14

Registered with
  • US (FDA)