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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
LED Light Therapy Masks (LumiLips FAC07NA)

GUANGDONG NEWDERMO BIOTECH CO., LTD

Cleared 2026-03-23

Registered with
  • US (FDA)
Adin Long Dental Implant System

Adin Dental Implant Systems Ltd

Cleared 2026-03-23

Registered with
  • US (FDA)
QuikFix External Fixator: Knee-Spanning Pack

Stabiliz Orthopaedics, LLC

Cleared 2026-03-23

Registered with
  • US (FDA)
True Definition DL

Ge Healthcare Japan Corporation

Cleared 2026-03-23

Registered with
  • US (FDA)
HyperSuture All Green Extension Line

Threadstone, LLC

Cleared 2026-03-23

Registered with
  • US (FDA)
CT Rembra RT; CT Areta RT; CT Rembra

Philips Healthcare (Suzhou) Co., Ltd.

Cleared 2026-03-23

Registered with
  • US (FDA)
MDx-Chex for BCN

Streck

Cleared 2026-03-23

Registered with
  • US (FDA)
SUPERA PERIPHERAL STENT SYSTEM

Abbott Vascular (Idef Technologies Inc)

Cleared 2026-03-20

Registered with
  • US (FDA)
XACT CAROTID STENT SYSTEM

Abbott Vascular, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
Arthrex Humeral Nails

Arthrex, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
ClaveQS™ Bag

ICU Medical, Inc

Cleared 2026-03-20

Registered with
  • US (FDA)
Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

Hangzhou Tappa Medical Technology Co, Ltd

Cleared 2026-03-20

Registered with
  • US (FDA)
Percutaneous Endoscopic Gastrostomy (PEG) Kit

Degania Silicone , Ltd.

Cleared 2026-03-20

Registered with
  • US (FDA)
Smart Fit TorsoCardiac 1.5T

Philips Healthcare (Suzhou) Co., Ltd.

Cleared 2026-03-20

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Livi Device

Liviwell, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
Noxturnal Web

Nox Medical Ehf

Cleared 2026-03-20

Registered with
  • US (FDA)
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

Fmd, LLC

Cleared 2026-03-20

Registered with
  • US (FDA)
NOMAD Pro 3

Dental Imaging Technologies Corporation

Cleared 2026-03-20

Registered with
  • US (FDA)
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

Nexstim Plc

Cleared 2026-03-20

Registered with
  • US (FDA)
nordicAudio (1.0)

Nordicneurolab

Cleared 2026-03-20

Registered with
  • US (FDA)
Electric wheelchair (JJW-7002, JJW-7003)

ZheJiang J&J Mobility Co., Ltd.

Cleared 2026-03-20

Registered with
  • US (FDA)
Valvuloplasty Balloon Catheter (ValvuloPro)

Dongguan TT Medical, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
HemosIL Factor V Leiden (APC Resistance V)

Instrumentation Laboratory (IL) Co.

Cleared 2026-03-20

Registered with
  • US (FDA)
TiLink-L Navigation Instruments

SurGenTec, LLC

Cleared 2026-03-20

Registered with
  • US (FDA)
SOMATOM X.cite; SOMATOM X.ceed

Siemens Medical Solutions USA, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
ARTHREX FIBERTAK SUTURE ANCHOR

Arthrex, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
Bifix Veneer LC, Bifix Veneer Try-In

Voco GmbH

Cleared 2026-03-20

Registered with
  • US (FDA)
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

Olympus Medical Systems Corporation

Cleared 2026-03-20

Registered with
  • US (FDA)
Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
FLOWRUNNER Aspiration System

Expanse Medical, Inc.

Cleared 2026-03-20

Registered with
  • US (FDA)
Derma-Gide

Geistlich-Pharma

Cleared 2026-03-19

Registered with
  • US (FDA)
Disposable Distal Cap

Mirco-Tech (Nanjing) Co., Ltd.

Cleared 2026-03-19

Registered with
  • US (FDA)
DiversiVy™ Facet Screw System

Vy Spine, LLC

Cleared 2026-03-19

Registered with
  • US (FDA)
AutoContour (RADAC V5)

Radformation

Cleared 2026-03-19

Registered with
  • US (FDA)
ELISIO™-H

NIPRO MEDICAL CORPORATION

Cleared 2026-03-19

Registered with
  • US (FDA)
Dia-X Sil Bite

DiaDent Group International

Cleared 2026-03-19

Registered with
  • US (FDA)
JWG-1

Yamaha Motor Co., Ltd.

Cleared 2026-03-19

Registered with
  • US (FDA)
Willow 24 Guidewire

Arbor Endovascular, LLC

Cleared 2026-03-19

Registered with
  • US (FDA)
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

St. shine Optical Co., Ltd.

Cleared 2026-03-19

Registered with
  • US (FDA)
CastleLoc Pectus Bar System

L&K BIOMED CO., LTD

Cleared 2026-03-19

Registered with
  • US (FDA)
Eversense E3 CGM System

Senseonics, Incorporated

Cleared 2026-03-19

Registered with
  • US (FDA)
Enroute 0.014'' Transcarotid Guidewire

Lake Region Medical

Cleared 2026-03-19

Registered with
  • US (FDA)
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

Spectranetics Corp.

Cleared 2026-03-19

Registered with
  • US (FDA)
  • EU (EUDAMED)
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Wuhan PHOMED Technology Company , Ltd.

Cleared 2026-03-19

Registered with
  • US (FDA)
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

MedShape, Inc.

Cleared 2026-03-18

Registered with
  • US (FDA)
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

O&M Halyard, Inc.

Cleared 2026-03-18

Registered with
  • US (FDA)
Safety Pen Needle

Ningbo Medsun Medical Co., Ltd.

Cleared 2026-03-18

Registered with
  • US (FDA)
  • EU (EUDAMED)
VISUREF 600

CARL ZEISS VISION GMBH

Cleared 2026-03-18

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
syngo.via RT Image Suite VC10

Varian Medical Systems inc

Cleared 2026-03-18

Registered with
  • US (FDA)
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)

Sangi Co, Ltd.

Cleared 2026-03-18

Registered with
  • US (FDA)