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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
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

Shenzhen OSTO Medical Technology Company Limited

Cleared 2026-09-06

Registered with
  • US (FDA)
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

Fidelity BioPharma Co.

Cleared 2026-09-06

Registered with
  • US (FDA)
LipoSurg ARTIST

NOUVAG AG

Cleared 2026-09-05

Registered with
  • US (FDA)
FreezeSpray TA

CRYOSURGERY, INC.

Cleared 2026-09-05

Registered with
  • US (FDA)
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Cleared 2026-09-04

Registered with
  • US (FDA)
NeoPEX™ Pre-Mixed Obturation Paste

NuSmile, Ltd.

Cleared 2026-09-04

Registered with
  • US (FDA)
FCT iStream Phase 2

FUJIFILM Corporation

Cleared 2026-09-04

Registered with
  • US (FDA)
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Cleared 2026-09-04

Registered with
  • US (FDA)
ActivaScrew™ Cannulated COM

Bioretec Ltd

Cleared 2026-09-04

Registered with
  • US (FDA)
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

Medtronic Xomed

Cleared 2026-09-04

Registered with
  • US (FDA)
KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O

Cleared 2026-09-04

Registered with
  • US (FDA)
ATTUNE Revision Knee System

DePuy Orthopaedics, Inc.

Cleared 2026-09-04

Registered with
  • US (FDA)
Surgical and Prosthetic Trays

Dentsply Sirona

Cleared 2026-09-04

Registered with
  • US (FDA)
3D-RD-S

Radiopharmaceutical Imaging and Dosimetry, LLC

Cleared 2026-09-04

Registered with
  • US (FDA)
  • UK (MHRA)
Gastric Alimetry

Alimetry , Ltd.

Cleared 2026-09-04

Registered with
  • US (FDA)
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

Sentinel Medical Technologies, LLC

Cleared 2026-09-04

Registered with
  • US (FDA)
NextMR Spine

MRI2CT, Inc.

Cleared 2026-09-04

Registered with
  • US (FDA)
70 NeuGlide Catheter

Piraeus Medical

Cleared 2026-09-04

Registered with
  • US (FDA)
Digital Indeflator INFLANTE

UAB Telemedicina

Cleared 2026-09-04

Registered with
  • US (FDA)
Peerbridge COR MDx (Cor MDx)

Peerbridge Health, Inc.

Cleared 2026-09-04

Registered with
  • US (FDA)
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

Siemens Healthcare Diagnostics Products Limited

Cleared 2026-09-04

Registered with
  • US (FDA)
Mayumi™ Thrombectomy System

MicroVention, Inc., d/b/a Terumo Neuro

Cleared 2026-09-03

Registered with
  • US (FDA)
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)

Orthocon, LLC

Cleared 2026-09-03

Registered with
  • US (FDA)
Helo Max Thrombectomy System (HEL2090)

Endovascular Engineering

Cleared 2026-09-03

Registered with
  • US (FDA)
Profisil Free

Kettenbach GmbH & Co. KG

Cleared 2026-09-03

Registered with
  • US (FDA)
M•care System (MW-20)

Marani Health, Inc.

Cleared 2026-09-03

Registered with
  • US (FDA)
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035

Filmecc Co., Ltd.

Cleared 2026-09-03

Registered with
  • US (FDA)
STEMI AI ECG Model

POWERFUL MEDICAL s.r.o.

Cleared 2026-09-03

Registered with
  • US (FDA)
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)

Philips Consumer Lifestyle

Cleared 2026-09-03

Registered with
  • US (FDA)
Tenax Laser Resistant Endotracheal Tube

Bryan Medical, Inc.

Cleared 2026-09-03

Registered with
  • US (FDA)
NEUROBLATE SYSTEM

MONTERIS MEDICAL CORPORATION

Cleared 2026-09-03

Registered with
  • US (FDA)
  • Canada (Health Canada)
Happy Health Blood Pressure Monitor

Happy Health, Inc.

Cleared 2026-09-03

Registered with
  • US (FDA)
Triton 1 System

Neptune Medical

Cleared 2026-09-03

Registered with
  • US (FDA)
Tempo Plating System; Ultra Compression Screw System

Pace Surgical

Cleared 2026-09-03

Registered with
  • US (FDA)
HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)

Maxigen Biotech, Inc.

Cleared 2026-09-03

Registered with
  • US (FDA)
Rezum System

Boston Scientific Corp

Cleared 2026-09-03

Registered with
  • US (FDA)
Trexo Theo

Trexo Robotics Inc.

Cleared 2026-09-02

Registered with
  • US (FDA)
Pivot Insulin Delivery System

Modular Medical, Inc.

Cleared 2026-09-02

Registered with
  • US (FDA)
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)

Zhengzhou PZ Laser Slim Technology Co Limited

Cleared 2026-09-02

Registered with
  • US (FDA)
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Cardinalhealth

Cleared 2026-09-02

Registered with
  • US (FDA)
I-View®

Hologic Inc

Cleared 2026-09-02

Registered with
  • US (FDA)
  • Canada (Health Canada)
Vivid Explorer/Vivid Advanced/Vivid Focus

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2026-09-02

Registered with
  • US (FDA)
ArthroTAK Tendon Anchor Kit

ArthroTAK, LLC

Cleared 2026-09-02

Registered with
  • US (FDA)
HYALOMATRIX

Anika Therapeutics, Inc

Cleared 2026-09-02

Registered with
  • US (FDA)
  • Canada (Health Canada)
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)

Flexicare Medical Ltd

Cleared 2026-09-02

Registered with
  • US (FDA)
Aevumed SUPERCYNCH™ Button System

Aevumed, Inc.

Cleared 2026-09-02

Registered with
  • US (FDA)
Ellian Enigma RF Device

Ellian Corp

Cleared 2026-09-02

Registered with
  • US (FDA)
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)

Serpex Medical, Inc.

Cleared 2026-09-02

Registered with
  • US (FDA)
Ruby Intravascular Catheter

Venocare, Inc.

Cleared 2026-09-02

Registered with
  • US (FDA)
Momentum Acetabular Cup System

United Orthopedic Corporation

Cleared 2026-09-02

Registered with
  • US (FDA)