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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
Arthrex Synergy Vision Imaging System

Arthrex, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
EUFLEXXA (1% SODIUM HYALURONATE)

Ferring Pharmaceuticals, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
ProZip Knotless Implant

Riverpoint Medical

Cleared 2025-10-16

Registered with
  • US (FDA)
Elos Accurate Hybrid Base

Elos Medtech Pinol A/S

Cleared 2025-10-16

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Re:Balans

Mode Sensors AS

Cleared 2025-10-16

Registered with
  • US (FDA)
Light Therapy Mask (1019055)

Merchsource, LLC

Cleared 2025-10-16

Registered with
  • US (FDA)
Medtronic MiniMed 630G System

Medtronic Minimed

Cleared 2025-10-16

Registered with
  • US (FDA)
NeurAxis IB-Stim (01-1020)

Neuraxis

Cleared 2025-10-16

Registered with
  • US (FDA)
TargetCool™ (RM-DT02W)

Recensmedical, Inc.

Cleared 2025-10-16

Registered with
  • US (FDA)
SYNGO, CT DUAL ENERGY

Siemens Medical Solutions USA, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
V-soft Line™ Barbed Surgical Suture (Various)

Feeltech Co., Ltd.

Cleared 2025-10-15

Registered with
  • US (FDA)
BioBrace® Extra-Articular Ligament Augmentation Kit

Conmed Corporation

Cleared 2025-10-15

Registered with
  • US (FDA)
Ophthalin; Nuvisc; Anikavisc

Anika Therapeutics, Inc

Cleared 2025-10-15

Registered with
  • US (FDA)
TargetCool-e

Recensmedical, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
ELEOS™ Limb Salvage System with NanoCept® Technology

Onkos Surgical, Inc

Cleared 2025-10-15

Registered with
  • US (FDA)
Sure-Fine Insulin Syringes

SHINA MED CORPORATION

Cleared 2025-10-15

Registered with
  • US (FDA)
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

Hand Biomechanics Lab, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
Bonafix Implant Abutments

Zentek Medical, LLC

Cleared 2025-10-15

Registered with
  • US (FDA)
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

Zoll Circulation

Cleared 2025-10-15

Registered with
  • US (FDA)
AGFA HealthCare Enterprise Imaging

Agfa Healthcare Corp.

Cleared 2025-10-15

Registered with
  • US (FDA)
InbellaMulti System

Inbella Medical, Inc.

Cleared 2025-10-15

Registered with
  • US (FDA)
IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)

Shenzhen Qiaochengli Technology Co., Ltd.

Cleared 2025-10-14

Registered with
  • US (FDA)
FlowArt® Vial Access Device Vented

Asset Medikal

Cleared 2025-10-14

Registered with
  • US (FDA)
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

Pureway Compliance, Inc.

Cleared 2025-10-14

Registered with
  • US (FDA)
PRESSON SPINAL FIXATION SYSTEM

Nexus Spine, LLC

Cleared 2025-10-14

Registered with
  • US (FDA)
Hemastyl(™) Wound Dressing

Rapid Nexus Nanotech Wound Solutions, Inc.

Cleared 2025-10-14

Registered with
  • US (FDA)
Community Containers (Flap and Daisy)

Keter Canada, Inc.

Cleared 2025-10-14

Registered with
  • US (FDA)
LIFEPAK 15 AC Power Adapter (41577-000333)

Physio-Control, Inc.

Cleared 2025-10-14

Registered with
  • US (FDA)
Demi Pro

META SYSTEMS CO, LTD

Cleared 2025-10-14

Registered with
  • US (FDA)
  • EU (EUDAMED)
Lithoblast Single Use Holmium Laser Fibers

Dawell Medical, LLC

Cleared 2025-10-14

Registered with
  • US (FDA)
Mini Superhawk Suture Anchor System

Responsive Arthroscopy, LLC

Cleared 2025-10-14

Registered with
  • US (FDA)
Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

Bone Solutions, Inc.

Cleared 2025-10-13

Registered with
  • US (FDA)
COVID-19 Detect Rapid Self -Test

InBios International, Inc.

Cleared 2025-10-12

Registered with
  • US (FDA)
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)

Shenzhen Nuon Medical Equipment Co., Ltd.

Cleared 2025-10-12

Registered with
  • US (FDA)
Geneo X Elite

Pollogen, Ltd.

Cleared 2025-10-12

Registered with
  • US (FDA)
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Canon Medical Systems Corporation

Cleared 2025-10-10

Registered with
  • US (FDA)
SoClean 3+

SOCLEAN INC.

Cleared 2025-10-10

Registered with
  • US (FDA)
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)

Foshan Jindi Electric Appliance Co., Ltd.

Cleared 2025-10-10

Registered with
  • US (FDA)
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
Tegaderm Post-Op Transparent Antimicrobial Dressing

Solventum Us, LLC

Cleared 2025-10-10

Registered with
  • US (FDA)
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

Olympus Medical Systems Corporation

Cleared 2025-10-10

Registered with
  • US (FDA)
HexaPLUS S OneDrill Implant System

Osseofuse, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Procept Biorobotics, Corporation

Cleared 2025-10-10

Registered with
  • US (FDA)
Yomi Robotic System

Neocis, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Gold Standard Diagnostics

Cleared 2025-10-10

Registered with
  • US (FDA)
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
Zeta Navigation System (ZNS131-US)

Zeta Surgical

Cleared 2025-10-10

Registered with
  • US (FDA)
LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)