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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.

3,664 devices · when each source was last refreshed

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

Device
Ion Endoluminal System (IF1000)

Intuitive Surgical, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
SwiftSight-Brain

Airs Medical, Inc.

Cleared 2025-09-23

Registered with
  • US (FDA)
  • Canada (Health Canada)
Santreva™-ATK Endovascular Revasculariztion Catheter

AngioSafe, Inc.

Cleared 2025-09-22

Registered with
  • US (FDA)
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System

Surgical Principals, Inc.

Cleared 2025-09-22

Registered with
  • US (FDA)
Babio® Virus Transport Kit (Non-inactivating)

JINAN BABIO BIOTECHNOLOGY CO, LTD

Cleared 2025-09-22

Registered with
  • US (FDA)
IC-Flow™ Imaging System 2.0

Diagnostic Green GmbH

Cleared 2025-09-22

Registered with
  • US (FDA)
ENDOFLATOR +

Karl Storz SE & CO.KG

Cleared 2025-09-22

Registered with
  • US (FDA)
Coated hip implants

Medacta International S.A.

Cleared 2025-09-19

Registered with
  • US (FDA)
VEGA

Ibramed Equipamentos Medicos

Cleared 2025-09-19

Registered with
  • US (FDA)
KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)

Cytocell Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
Alegria Flash ENA Screen

Zeus Scientific, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

NAKANISHI INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Sonicaid Team3

HUNTLEIGH HEALTHCARE LTD.

Cleared 2025-09-19

Registered with
  • US (FDA)
WALLSTENT (CAROTID) ENDOPROSTHESIS

Boston Scientific Corp

Cleared 2025-09-19

Registered with
  • US (FDA)
  • AU (TGA)
IPGTFL-02

Ipg Medical Corporation

Cleared 2025-09-19

Registered with
  • US (FDA)
Portable mesh nebulizer (JM821)

Shenzhen Jermei Medical Device Technology Co,Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)
TAPESTRY Biointegrative Implant

Embody, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Bunkerhill ECG-EF

Bunkerhill Health

Cleared 2025-09-19

Registered with
  • US (FDA)
xR IVD

Tempus AI, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Single Use Suction-Evacuation Ureteral Access Sheath

Anhui Happiness Workshop Medical Instruments Co, Ltd

Cleared 2025-09-19

Registered with
  • US (FDA)
Videa Dental AI

Videahealth, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
  • UK (MHRA)
BondEase 2 Topical Skin Adhesive

Optmed, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

Olympus Medical Systems Corporation

Cleared 2025-09-19

Registered with
  • US (FDA)
Well-Root PT

Vericom Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)
  • UK (MHRA)
EQUIA LC ONE

GC AMERICA INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Purema H Hemoconcentrator - Pediatric

Medica USA, Inc.

Cleared 2025-09-19

Registered with
  • US (FDA)
Impact PEEK Union Nail System

Nvision Biomedical Technologies, LLC

Cleared 2025-09-19

Registered with
  • US (FDA)
UniBur

NAKANISHI INC.

Cleared 2025-09-19

Registered with
  • US (FDA)
Unscented menstrual three-piece applicator tampon

Unibeauty (Hubei) Technology Co., Ltd.

Cleared 2025-09-19

Registered with
  • US (FDA)
IMMULITE, IMMULITE 1000 ANTI-HBS AND IMMULITE 2000 ANTI-HBS

Siemens Healthcare Diagnostics Products Limited

Cleared 2025-09-18

Registered with
  • US (FDA)
  • UK (MHRA)
Normatec Elite Hip

Normatec Industries, LP

Cleared 2025-09-18

Registered with
  • US (FDA)
Magic InBra

Medela, Inc.

Cleared 2025-09-18

Registered with
  • US (FDA)
  • Canada (Health Canada)
Axial3D Insight

Axial Medical Printing Limited

Cleared 2025-09-18

Registered with
  • US (FDA)
InnerView System

Perimetrics, Inc.

Cleared 2025-09-18

Registered with
  • US (FDA)
  • AU (TGA)
Sunny Plus (Sunny)

ShenB Co., Ltd.

Cleared 2025-09-18

Registered with
  • US (FDA)
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))

Mobarn Medical Devices, LLC

Cleared 2025-09-18

Registered with
  • US (FDA)
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

Olympus Medical Systems Corporation

Cleared 2025-09-18

Registered with
  • US (FDA)
Electric Wheelchair (Model P2)

Superpi Robot Co., Ltd.

Cleared 2025-09-18

Registered with
  • US (FDA)
IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY

Siemens Healthcare Diagnostics Products Limited

Cleared 2025-09-18

Registered with
  • US (FDA)
Ruthless Spine RJB

Ruthless, LLC Dba Ruthless Spine

Cleared 2025-09-17

Registered with
  • US (FDA)
Trident(R), ABC(R)

Howmedica Osteonics Corp.

Cleared 2025-09-17

Registered with
  • US (FDA)
Double Tube Herbst Appliance

The Tmj Clinic PC

Cleared 2025-09-17

Registered with
  • US (FDA)
PlasmaFlow X Compression Sleeve Device (XPF0001)

Manamed, Inc.

Cleared 2025-09-17

Registered with
  • US (FDA)
MARGINPROBE SYSTEM

Dilon Medical Technologies, Ltd.

Cleared 2025-09-17

Registered with
  • US (FDA)
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Pegavision Corporation

Cleared 2025-09-17

Registered with
  • US (FDA)
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

Shenzhen Yicai Health Technology Co., Ltd.

Cleared 2025-09-17

Registered with
  • US (FDA)
Carpentier-Edwards Physio Annuloplasty Ring (4450)

Edwards Lifesciences, LLC

Cleared 2025-09-17

Registered with
  • US (FDA)
ECHELON Synergy

FUJIFILM Corporation

Cleared 2025-09-17

Registered with
  • US (FDA)
  • EU (EUDAMED)
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

Kamemizu Chemical Industry Co., Ltd.

Cleared 2025-09-17

Registered with
  • US (FDA)