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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
Protrieve Sheath

Inari Medical, Inc.

Cleared 2025-10-29

Registered with
  • US (FDA)
Telescope Guide Extension Catheter

Medtronic, Ireland

Cleared 2025-10-29

Registered with
  • US (FDA)
JARVIS Diaphyseal Stem Standard

FH INDUSTRIE

Cleared 2025-10-29

Registered with
  • US (FDA)
LOGIQ E10

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Cleared 2025-10-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
3D Laparoscope

Guangdong Optomedic Technologies, Inc.

Cleared 2025-10-29

Registered with
  • US (FDA)
SER Pen Carain MicroSystem (MP1209SP)

Su-Ko Technologies, LLC

Cleared 2025-10-29

Registered with
  • US (FDA)
Arthrex SutureTak Suture Anchor

Arthrex, Inc.

Cleared 2025-10-29

Registered with
  • US (FDA)
Medi Lift Essential Eye Mask

Ya-Man, Ltd.

Cleared 2025-10-29

Registered with
  • US (FDA)
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch

BAYLIS MEDICAL TECHNOLOGIES INC.

Cleared 2025-10-28

Registered with
  • US (FDA)
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

Wellell Inc

Cleared 2025-10-28

Registered with
  • US (FDA)
ZIRCONOMER P

Shofu Dental Corp.

Cleared 2025-10-28

Registered with
  • US (FDA)
Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Volcano Corporation (Dba Philips Image Guided Therapy Device

Cleared 2025-10-28

Registered with
  • US (FDA)
UniSpace® TPLIF Cage

CG MedTech Co., Ltd.

Cleared 2025-10-28

Registered with
  • US (FDA)
Yomi S Robotic System

Neocis, Inc.

Cleared 2025-10-28

Registered with
  • US (FDA)
DBP-1400-ABE and DBP-2003- ABE

Aed Battery Exchange, LLC

Cleared 2025-10-28

Registered with
  • US (FDA)
Navigated Instruments

Tyber Medical, LLC

Cleared 2025-10-28

Registered with
  • US (FDA)
FINE Osteotomy

Bodycad Laboratories, Inc.

Cleared 2025-10-28

Registered with
  • US (FDA)
Blood Pressure Monitor (B73, BE23T)

Shenzhen Jamr Technology Co., Ltd.

Cleared 2025-10-27

Registered with
  • US (FDA)
Electric Breast Pump (HL-3058, F5112)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

Cleared 2025-10-27

Registered with
  • US (FDA)
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion

W. L. Gore and Associates, Inc.

Cleared 2025-10-27

Registered with
  • US (FDA)
  • UK (MHRA)
Disposable Vinyl Examination Gloves

Viet Phu Trade and Import Export Co., Ltd.

Cleared 2025-10-27

Registered with
  • US (FDA)
Patriot Duo

Patriot Laser, LLC

Cleared 2025-10-27

Registered with
  • US (FDA)
Electric Breast Pump (HL-3060, F5113)

Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

Cleared 2025-10-27

Registered with
  • US (FDA)
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.

Cleared 2025-10-27

Registered with
  • US (FDA)
TECHFIT Patient-Specific Cranial System

Techfit Digital Surgery, Inc.

Cleared 2025-10-27

Registered with
  • US (FDA)
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

Affinity Biosensors

Cleared 2025-10-27

Registered with
  • US (FDA)
OsteoCentric Navigated Instruments System

Osteocentric Technologies

Cleared 2025-10-27

Registered with
  • US (FDA)
cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging Inc

Cleared 2025-10-27

Registered with
  • US (FDA)
Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

Cleared 2025-10-24

Registered with
  • US (FDA)
Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Cleared 2025-10-24

Registered with
  • US (FDA)
Mobile X-ray unit (!M1)

Solutions For Tomorrow AB

Cleared 2025-10-24

Registered with
  • US (FDA)
Vesalio Peripheral System

Vesalio

Cleared 2025-10-24

Registered with
  • US (FDA)
LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Philips Medical Systems Nederland BV

Cleared 2025-10-24

Registered with
  • US (FDA)
Expandable Titanium PLIF/TLIF System

Spectrum Spine, LLC

Cleared 2025-10-24

Registered with
  • US (FDA)
Glucose2

Abbott Ireland

Cleared 2025-10-24

Registered with
  • US (FDA)
Fule Spinal Fixation System

Beijing Fule Science & Technology Development Co., Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
Parietene™ Flat Sheet Mesh

Medtronic - Sofradim Production

Cleared 2025-10-24

Registered with
  • US (FDA)
Atalante X

Wandercraft Sas

Cleared 2025-10-24

Registered with
  • US (FDA)
  • EU (EUDAMED)
VersaD Delivery Catheter

Unity Medical, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
BAUSCH & LOMB SOFLENS(R) (POLYMACON) CONTACT LENS

Bausch & Lomb Incorporated

Cleared 2025-10-24

Registered with
  • US (FDA)
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Olympus Medical Systems Corporation

Cleared 2025-10-24

Registered with
  • US (FDA)
  • Canada (Health Canada)
AngioVac Cannula

AngioDynamics, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
Hushd Pro Z-Link

Good Sleep CO Pte , Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
CoroFlow Cardiovascular System

Coroventis Research AB

Cleared 2025-10-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
CD HORIZON SPINAL SYSTEM

MEDTRONIC SOFAMOR DANEK USA, INC.

Cleared 2025-10-24

Registered with
  • US (FDA)
  • AU (TGA)
Cryon-X Cold Compression

Jkh Health Co., Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
Cocoon Solo (DX-7020s)

Dexcowin Global, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
Medline Bag Decanter

Medline Industries, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)
AccuCheck

Manteia Technologies Co., Ltd.

Cleared 2025-10-24

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

Medivance, Inc.

Cleared 2025-10-24

Registered with
  • US (FDA)