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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.

3,686 devices · when each source was last refreshed

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

Device
RESQCPR SYSTEM

Zoll Medical Corp

Cleared 2026-08-27

Registered with
  • US (FDA)
1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

Zhengzhou PZ Laser Slim Technology Co Limited

Cleared 2026-08-27

Registered with
  • US (FDA)
Iconix Knotless T

Riverpoint Medical

Cleared 2026-08-27

Registered with
  • US (FDA)
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

GEBAUER COMPANY

Cleared 2026-08-27

Registered with
  • US (FDA)
GC85A

Samsung Electronics Co., Ltd.

Cleared 2026-08-27

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
EasyCare Tx 2

ResMed PTY Ltd

Cleared 2026-08-27

Registered with
  • US (FDA)
  • Canada (Health Canada)
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)

Olympus Medical Systems Corporation

Cleared 2026-08-27

Registered with
  • US (FDA)
Glidewell™ Denture Base Resin

Prismatik Dentalcraft, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
Scarlet Pro (Scarlet Pro)

VIOL Medical Co., Ltd.

Cleared 2026-08-27

Registered with
  • US (FDA)
LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus

DiaSorin, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
35 Helix Guidewire

Piraeus Medical

Cleared 2026-08-27

Registered with
  • US (FDA)
Aveir™ Leadless System

Abbott Medical

Cleared 2026-08-27

Registered with
  • US (FDA)
LCS TOTAL KNEE SYSTEM

Depuy, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
Minima Pro Stent System

Renata Medical, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
GenesisX RMN

Stereotaxis, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
  • UK (MHRA)
Perclose ProStyle Suture-Mediated Closure and Repair System

Abbott Vascular, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
  • UK (MHRA)
Gastrointestinal Videoscope Olympus GIF-2T1500

Olympus Medical Systems Corporation

Cleared 2026-08-27

Registered with
  • US (FDA)
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System

Ascensia Diabetes Care

Cleared 2026-08-27

Registered with
  • US (FDA)
Disposable Distal Attachment D-201-13404

Olympus Medical Systems Corporation

Cleared 2026-08-27

Registered with
  • US (FDA)
Optiflow Oxygen Kit (AA484J)

Fisher &Paykel Healthcare , Ltd.

Cleared 2026-08-27

Registered with
  • US (FDA)
CERAMAX® Ceramic Total Hip System

DePuy Orthopaedics, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)

Ram.Shaw Pte. , Ltd.

Cleared 2026-08-27

Registered with
  • US (FDA)
Dexus Prosthetic System (MSL2, MSR2)

Zhejiang Qiangnao Technology Co.,Ltd

Cleared 2026-08-27

Registered with
  • US (FDA)
ColoSense®

Geneoscopy, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

Berkeley Advanced Biomaterials, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
BAGUERA®C Cervical Disc Prosthesis

Spineart USA, Inc.

Cleared 2026-08-27

Registered with
  • US (FDA)
Duo Venous Stent System

Philips Image Guided Therapy Corporation

Cleared 2026-08-26

Registered with
  • US (FDA)
MRIA Radiation Therapy Information System (MRIA)

Manteia Technologies Co., Ltd.

Cleared 2026-08-26

Registered with
  • US (FDA)
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns

Principle & Will Co., Ltd.

Cleared 2026-08-26

Registered with
  • US (FDA)
Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

Maquet Critical Care AB

Cleared 2026-08-26

Registered with
  • US (FDA)
SimpleScreen™ CRC

Freenome Ltd

Cleared 2026-08-26

Registered with
  • US (FDA)
GEL-ONE(R)

Seikagaku Corp.

Cleared 2026-08-26

Registered with
  • US (FDA)
Rapid fFN for the TLiIQ System

Hologic Inc

Cleared 2026-08-26

Registered with
  • US (FDA)
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)

Joytech Healthcare Co. , Ltd.

Cleared 2026-08-26

Registered with
  • US (FDA)
OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor

Sony Corporation

Cleared 2026-08-26

Registered with
  • US (FDA)
Atellica IM total PSA II (tPSAII)

Siemens Healthcare Diagnostics

Cleared 2026-08-26

Registered with
  • US (FDA)
  • EU (EUDAMED)
LithoVue Elite Digital Flexible Ureteroscope System

Boston Scientific Corp

Cleared 2026-08-26

Registered with
  • US (FDA)
VariLift-C Cervical Interbody Fusion System

Wenzel Spine

Cleared 2026-08-26

Registered with
  • US (FDA)
Ponto 5 Mini; Ponto 5 Superpower

Oticon Medical AB

Cleared 2026-08-26

Registered with
  • US (FDA)
SUPARTZ FX/VISCO-3

Seikagaku Corp.

Cleared 2026-08-26

Registered with
  • US (FDA)
INFUSE BONE GRAFT

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2026-08-26

Registered with
  • US (FDA)
  • Canada (Health Canada)
GraftGun Universal Graft Delivery System (GDS)

SurGenTec, LLC

Cleared 2026-08-26

Registered with
  • US (FDA)
StimTrial Neuromodulation System

Bioventus LLC

Cleared 2026-08-26

Registered with
  • US (FDA)
HOPKINS Telescopes for Arthroscopy

Karl Storz SE & CO.KG

Cleared 2026-08-26

Registered with
  • US (FDA)
INFUSE BONE GRAFT

Medtronic, Inc

Cleared 2026-08-26

Registered with
  • US (FDA)
Heartvue.Proton

Heartvue.ai, Inc.

Cleared 2026-08-26

Registered with
  • US (FDA)
FARAPULSE™ Pulsed Field Ablation System

Farapulse, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

Sterilance Medical(Suzhou), Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)
MONOFIX PDO

Samyang Biopharm Corporation

Cleared 2026-08-25

Registered with
  • US (FDA)
  • EU (EUDAMED)
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

Abbott Diabetes Care, Inc.

Cleared 2026-08-25

Registered with
  • US (FDA)