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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
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)
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 assay, Control and 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

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
  • Canada (Health Canada)
DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet

Medtronic, Inc

Cleared 2025-10-10

Registered with
  • US (FDA)
Eleganz IM Threaded Nail System (IM Threaded Nail System)

Dev4

Cleared 2025-10-10

Registered with
  • US (FDA)
LIAISON® XL MUREX HBsAg Confirmatory

DiaSorin, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
  • Canada (Health Canada)
RelayPlus Thoracic Stent-Graft System

Bolton Medical, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
  • UK (MHRA)
Verruca-Freeze H Plus

CRYOSURGERY, INC.

Cleared 2025-10-10

Registered with
  • US (FDA)
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

Acon Laboratories, Inc.

Cleared 2025-10-10

Registered with
  • US (FDA)
DeGen Medical Latitude-C AM Cervical Interbody Fusion System

Degen Medical

Cleared 2025-10-10

Registered with
  • US (FDA)
Collagen Wound Dressing

Winner Medical Co, Ltd

Cleared 2025-10-10

Registered with
  • US (FDA)
DIASAFEplusUS (F00013010)

Fresenius Medical Care Renal Therapies Group, LLC

Cleared 2025-10-09

Registered with
  • US (FDA)
Invisalign Specifix Attachment System

Align Technology Ltd

Cleared 2025-10-09

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

COTTON HIGH TECH, S.L.

Cleared 2025-10-09

Registered with
  • US (FDA)
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

Advin Biotech

Cleared 2025-10-09

Registered with
  • US (FDA)
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

Shenzhen Jianchao Intelligent Technology Co., Ltd.

Cleared 2025-10-09

Registered with
  • US (FDA)
ORA Method LED Gua Sha (GS-04)

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2025-10-09

Registered with
  • US (FDA)
cleadew GP hydra one

Ophtecs Corporation

Cleared 2025-10-09

Registered with
  • US (FDA)
  • EU (EUDAMED)
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)

NIHON KOHDEN CORPORATION

Cleared 2025-10-09

Registered with
  • US (FDA)