HaRi
Start Free→

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.

3,670 devices · when each source was last refreshed

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

Device
TactiFlex™ Ablation Catheter, Sensor Enabled™

Abbott Medical

Cleared 2026-09-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
ErgoSteel (ES0001/696)

Strongback Mobility AG C/O Blueaudit GmbH

Cleared 2026-09-22

Registered with
  • US (FDA)
Echo-2

Neko Health AB

Cleared 2026-09-22

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Spinal Cord Stimulation (SCS)

Boston Scientific Corp

Cleared 2026-09-22

Registered with
  • US (FDA)
IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

Siemens Healthcare Diagnostics

Cleared 2026-09-22

Registered with
  • US (FDA)
IMMULITE 2000 AFP

Siemens Healthcare Diagnostics

Cleared 2026-09-22

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

Spineart USA, Inc.

Cleared 2026-09-22

Registered with
  • US (FDA)
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

Bh Group Us, LLC

Cleared 2026-09-22

Registered with
  • US (FDA)
OtoCompanion (Version 1.0)

Ironsides Medical, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO

Shanghai Personage Hygiene Products Co., Ltd.

Cleared 2026-09-21

Registered with
  • US (FDA)
PD-L1 IHC 22C3 pharmDx (Dako Omnis)

Agilent Technologies, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
BellaTek Bars

ZimVie US Corp LLC

Cleared 2026-09-21

Registered with
  • US (FDA)
MAGE-A4 IHC 1F9 pharmDx

Agilent Technologies, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
TriSalus TriNav Advance Infusion System

Trisalus Life Sciences

Cleared 2026-09-21

Registered with
  • US (FDA)
ZYLOX Hippo PTA Balloon Dilatation Catheter

Zylox Medtech Co., Ltd.

Cleared 2026-09-21

Registered with
  • US (FDA)
F.A.S.T Screw

Steps Ortho

Cleared 2026-09-21

Registered with
  • US (FDA)
CORE*IT DUAL

Spident Co., Ltd.

Cleared 2026-09-21

Registered with
  • US (FDA)
  • UK (MHRA)
Disposable Ureteral Access Sheath

Yangzhou Fartley Medical Instrument Technology Co,., Ltd.

Cleared 2026-09-21

Registered with
  • US (FDA)
HERCEPTEST

Agilent Technologies Singapore (International) Pte Ltd

Cleared 2026-09-21

Registered with
  • US (FDA)
  • AU (TGA)
KARL STORZ TIPCAM1 Rubina

KALR STORZ SE & Co. KG

Cleared 2026-09-21

Registered with
  • US (FDA)
PD-L1 IHC 28-8 pharmDx

Agilent Technologies, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Access NT-proBNP

Beckman Coulter, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
Rapid Platform (R6.7)

Ischemaview, Inc.

Cleared 2026-09-21

Registered with
  • US (FDA)
NEXUS Aortic Arch Stent Graft System

Endospan Ltd

Cleared 2026-09-21

Registered with
  • US (FDA)
  • UK (MHRA)
Electric Scooter (FDB08, FDB08A, FDB12)

Anhui Jbh Medical Apparatus Co., Ltd.

Cleared 2026-09-19

Registered with
  • US (FDA)
Dynamis Pro Family

Fotona D.D.

Cleared 2026-09-19

Registered with
  • US (FDA)
SmartIPL_NI System

Lumenis Be Ltd

Cleared 2026-09-19

Registered with
  • US (FDA)
FoundationOne Liquid CDx (F1LCDx)

Foundation Medicine, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Integra Lifesciences Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
UNIDRIVE Select System

Karl Storz SE & CO.KG

Cleared 2026-09-18

Registered with
  • US (FDA)
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)

ICU Medical, Inc

Cleared 2026-09-18

Registered with
  • US (FDA)
Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour

Q-Med AB

Cleared 2026-09-18

Registered with
  • US (FDA)
  • AU (TGA)
HiResolution™ Bionic Ear System

Advanced Bionics

Cleared 2026-09-18

Registered with
  • US (FDA)
  • AU (TGA)
Integra® Dermal Regeneration Template

Integra Lifesciences Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
VacHeal Negative Pressure Wound Therapy System

VacHeal, LLC

Cleared 2026-09-18

Registered with
  • US (FDA)
Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated

Cleared 2026-09-18

Registered with
  • US (FDA)
Elucid PlaqueIQ

Elucid Bioimaging, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
Collastat™ Absorbable Collagen Hemostatic Sponge, Collastat™ Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I

Integra Lifesciences Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
Dental Diode Laser Device (Laser-Pen)

Guilin Kevin Peter Technology Co Ltd

Cleared 2026-09-18

Registered with
  • US (FDA)
enHAnce PEEK Bunion System

Nvision Biomedical Technologies, LLC

Cleared 2026-09-18

Registered with
  • US (FDA)
SELUTION SLR™ 014 PTCA Drug-Eluting Balloon

MedAlliance, LLC

Cleared 2026-09-18

Registered with
  • US (FDA)
CrossFAST Integrated Microcatheter Advanced Delivery System

Vantis Vascular, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
SLIT LAMP SL-D4 (TYPE LED)

Topcon Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Drainage Catheter

Canyon Medical, Inc.

Cleared 2026-09-18

Registered with
  • US (FDA)
  • EU (EUDAMED)
25G Huber Needle

Martech Medical Products

Cleared 2026-09-18

Registered with
  • US (FDA)
SURGIFLO HEMOSTATIC MATRIX KIT

Ferrosan Meidcal Devices A/S

Cleared 2026-09-18

Registered with
  • US (FDA)
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)

ONE BEAUTY Technology Co., Ltd.

Cleared 2026-09-18

Registered with
  • US (FDA)
Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form

Integra Lifesciences Corp.

Cleared 2026-09-18

Registered with
  • US (FDA)
Hyperdrive 35 Guidewire

Rapid-Medical , Ltd.

Cleared 2026-09-18

Registered with
  • US (FDA)
Pathfinder Endoscope Overtube

Neptune Medical

Cleared 2026-09-18

Registered with
  • US (FDA)
  • EU (EUDAMED)