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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
Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

Cleared 2026-03-16

Registered with
  • US (FDA)
Millipede System

Perfuze, Ltd.

Cleared 2026-03-16

Registered with
  • US (FDA)
APTUS Shoulder Proximal Humerus System, PentaLock 3.5

Medartis, Inc.

Cleared 2026-03-16

Registered with
  • US (FDA)
SINEFIX

BAAT Medical Products B.V.

Cleared 2026-03-16

Registered with
  • US (FDA)
CGuard Prime Carotid Stent System

Inspiremd, Ltd.

Cleared 2026-03-16

Registered with
  • US (FDA)
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

Technomed Europe

Cleared 2026-03-15

Registered with
  • US (FDA)
Prismaflex TPE2000 Set

VANTIVE US HEALTHCARE LLC

Cleared 2026-03-13

Registered with
  • US (FDA)
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

SHENZHEN KINGBOOM TECHNOLOGY CO., LTD

Cleared 2026-03-13

Registered with
  • US (FDA)
Pentacam® Cornea OCT

OCULUS Optikgeräte GmbH

Cleared 2026-03-13

Registered with
  • US (FDA)
InferCare RECIST

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Cleared 2026-03-13

Registered with
  • US (FDA)
Embrace Neonatal MRI System

Aspect Imaging, Ltd.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
IASIS i2 Relaxation Neurofeedback System

Iasis Technologies

Cleared 2026-03-13

Registered with
  • US (FDA)
Extremity CT Imaging System

Mars Bioimaging , Ltd.

Cleared 2026-03-13

Registered with
  • US (FDA)
TheraSphere 360™ Y-90 Management Platform

Boston Scientific Corp

Cleared 2026-03-13

Registered with
  • US (FDA)
Access anti-HBc IgM

Beckman Coulter, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Aeka Imaging

Good Methods Global, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

Pressure Products Medical Device Manufacturing, LLC

Cleared 2026-03-13

Registered with
  • US (FDA)
Permatage Flowable, Settable Bone Paste

Orthocon, LLC

Cleared 2026-03-13

Registered with
  • US (FDA)
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

Becton Dickinson and Company

Cleared 2026-03-13

Registered with
  • US (FDA)
Niti-S SPAXUS Stent

Taewoong Medical Co., Ltd.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

Abbott Medical

Cleared 2026-03-13

Registered with
  • US (FDA)
OptiMap Catheter - 50mm (OPTI-CATH2-50)

Cortex, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
GenBody COVID-19 Ag Home Test

GenBody Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
DURASPHERE INJECTABLE BULKING AGENT

Carbon Medical Technologies, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
LungFit PH

Beyond Air, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Aquilion ServeSP (TSX-307B) V2.0

Canon Medical Systems Corporation

Cleared 2026-03-13

Registered with
  • US (FDA)
BARE Wireguided Balloon Dilation Catheter (1235)

GIE MEDICAL, INC.

Cleared 2026-03-13

Registered with
  • US (FDA)
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

Medtronic Navigation Inc

Cleared 2026-03-13

Registered with
  • US (FDA)
Promogran Prisma™ Collagen Matrix with ORC and Silver

Solventum Germany GmbH

Cleared 2026-03-13

Registered with
  • US (FDA)
  • AU (TGA)
New Wave System

Zeto, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

BIONIT LABS SRL

Cleared 2026-03-12

Registered with
  • US (FDA)
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

Spectrum Medical Ltd

Cleared 2026-03-12

Registered with
  • US (FDA)
MiniMed Flex pump

Medtronic Minimed

Cleared 2026-03-12

Registered with
  • US (FDA)
VantageTM Lumbar Decompression Kit

Allevion Medical, LLC

Cleared 2026-03-12

Registered with
  • US (FDA)
InVera Infusion Device

Invera Medical

Cleared 2026-03-12

Registered with
  • US (FDA)
  • EU (EUDAMED)
VPAP Pediatric Face Mask

Hsiner Co., Ltd.

Cleared 2026-03-12

Registered with
  • US (FDA)
Dental X-RAY Unit (AJX200)

Guangzhou Ajax Medical Equipment Co., Ltd.

Cleared 2026-03-12

Registered with
  • US (FDA)
Medical Mesh Nebulizer (AirICU Max+)

AIRICU, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
Power Mobility Scooter (MJMA01, MJMA02)

Nanjing MIJO Technology Co, Ltd

Cleared 2026-03-12

Registered with
  • US (FDA)
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

Signature Orthopaedics Pty Ltd

Cleared 2026-03-12

Registered with
  • US (FDA)
MEDPOR Customized Implant Kit

Stryker Leibinger

Cleared 2026-03-12

Registered with
  • US (FDA)
implaFit® short stems

Implantcast GmbH

Cleared 2026-03-12

Registered with
  • US (FDA)
Mimics Thoracic Planner

Materialise N.V

Cleared 2026-03-12

Registered with
  • US (FDA)
  • UK (MHRA)
Genadyne ASTRA NPWT

Genadyne Biotechnologies, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
LungFlow Basket Catheter

Free Flow Medical, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
Affixus Retrograde Femoral Nailing System

Zimmer Inc

Cleared 2026-03-12

Registered with
  • US (FDA)
Trax EX Anchor

Trax Surgical

Cleared 2026-03-12

Registered with
  • US (FDA)
TRIDYNE VASCULAR SEALANT

Neomend, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
PROGEL™ Pleural Air Leak Sealant

Neomend, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Spectrum Medical Ltd

Cleared 2026-03-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)