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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.

3,689 devices · when each source was last refreshed

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

Device
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)
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)
LungFit PH

Beyond Air, Inc.

Cleared 2026-03-13

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
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)
  • Canada (Health Canada)
  • 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)
MiniMed Flex Pump

Medtronic Minimed

Cleared 2026-03-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
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)
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)
RESTYLANE

Q-Med AB

Cleared 2026-03-12

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA

Cleared 2026-03-12

Registered with
  • US (FDA)
Liv Pre-lubricated Intermittent Catheter

HR HealthCare

Cleared 2026-03-12

Registered with
  • US (FDA)
Tyto Stethoscope (G3)

Tyto Care , Ltd.

Cleared 2026-03-12

Registered with
  • US (FDA)
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)

A Cute Baby, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
Urocross Expander System (Model Numbers ES2018 and ES3025)

Prodeon Medical, Inc.

Cleared 2026-03-12

Registered with
  • US (FDA)
Taurus Clip

Taurus Endoscopy

Cleared 2026-03-12

Registered with
  • US (FDA)
Zionic Pro Max (EMS)

Termosalud, S.L.

Cleared 2026-03-12

Registered with
  • US (FDA)
Tigertriever 25 Revascularization Device

Rapid-Medical , Ltd.

Cleared 2026-03-12

Registered with
  • US (FDA)
  • EU (EUDAMED)
Precision7; Precision7 for Astigmatism; Precision7 Multifocal

Alcon Laboratories

Cleared 2026-03-11

Registered with
  • US (FDA)
INHANCE™ Reverse Shoulder System

Depuy Ireland UC

Cleared 2026-03-11

Registered with
  • US (FDA)
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

Carestream Health, Inc.

Cleared 2026-03-11

Registered with
  • US (FDA)
da Vinci Force Feedback Instruments

Intuitive Surgical, Inc.

Cleared 2026-03-11

Registered with
  • US (FDA)
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

Kulzer, LLC

Cleared 2026-03-11

Registered with
  • US (FDA)
Xpert Hand

Newclip Technics S.A.S

Cleared 2026-03-11

Registered with
  • US (FDA)
Venous Return Cannulae

LivaNova USA Inc

Cleared 2026-03-11

Registered with
  • US (FDA)
LUOFUCON® Antimicrobial Wound Gel

Huizhou Foryou Medical Co., Ltd.

Cleared 2026-03-11

Registered with
  • US (FDA)
Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

Shenzhen Chuangtong Yigou Technology Co., Ltd.

Cleared 2026-03-11

Registered with
  • US (FDA)