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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.

3,400 devices · when each source was last refreshed

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

Device
MySleepDash

Somnetics International, Inc. (Dba Transcend Inc)

Cleared 2026-04-17

Registered with
  • US (FDA)
EdgeFlow UW20

Edgecare, Inc.

Cleared 2026-04-17

Registered with
  • US (FDA)
VISTAKON® (etafilcon A) lenses

Vistakon, Johnson & Johnson Vision Products, Inc.

Cleared 2026-04-17

Registered with
  • US (FDA)
TITAN Nail; APTUS K-Wire System

Medartis, Inc.

Cleared 2026-04-17

Registered with
  • US (FDA)
XplantR Explant Tool

Hjarta Care, LLC

Cleared 2026-04-17

Registered with
  • US (FDA)
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)

Pontemedag

Cleared 2026-04-17

Registered with
  • US (FDA)
ARx® SAI Implant System

Life Spine, LLC

Cleared 2026-04-16

Registered with
  • US (FDA)
Julva Velvé Water-Based Personal Lubricant

Golden Isles Medical, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Freedom DS™ Decompression System

SPINAL SIMPLICITY LLC

Cleared 2026-04-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube

Shenzhen Maiwei Biotech Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
Hot Pink Pad Warming System

Xodus Medical, Inc.

Cleared 2026-04-16

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

Advanced Bionics

Cleared 2026-04-16

Registered with
  • US (FDA)
  • AU (TGA)
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)

Bright Uro, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Foundation Surgical Navigated Lateral Disc Prep Instruments

Foundation Surgical Group, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Volt™ PFA Catheter, Sensor Enabled™

Abbott Medical

Cleared 2026-04-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm)

Edwards Lifesciences, LLC

Cleared 2026-04-16

Registered with
  • US (FDA)
Verisafe Safety Sterile Needles (SSN)

Promisemed Hangzhou Meditech Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,

Strauss Surgical USA

Cleared 2026-04-16

Registered with
  • US (FDA)
Disposable Radiofrequency Cannula

Abbott Medical

Cleared 2026-04-16

Registered with
  • US (FDA)
  • Canada (Health Canada)
Enso for Migraine

Hinge Health, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Endoflux™ Biliary & Pancreatic Stent Sets

Medi-Globe GmbH

Cleared 2026-04-16

Registered with
  • US (FDA)
Zenith Micro Guidewire

Suzhou Zenith Vascular SciTech Limited

Cleared 2026-04-16

Registered with
  • US (FDA)
ClearTip TBNA Type

Finemedix Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
ORIO-3D Cage System

Spinecraft, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Next Generation 088 Catheter

Balt USA, LLC

Cleared 2026-04-16

Registered with
  • US (FDA)
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
Insufflator (OPTO-IFL1000)

Guangdong Optomedic Technologies, Inc.

Cleared 2026-04-16

Registered with
  • US (FDA)
Redermo Wound Matrix

Beijing Kreate Medical Co., Ltd.

Cleared 2026-04-16

Registered with
  • US (FDA)
SCULPTRA AND SCULPTRA AESTHETIC

Q-Med AB

Cleared 2026-04-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965)

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
VERIQA RT EPID 3D

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

Cleared 2026-04-15

Registered with
  • US (FDA)
Refobacin Bone Cement R (110034355)

Biomet France

Cleared 2026-04-15

Registered with
  • US (FDA)
Diode Laser Therapy Systems (V19)

Weifang Mingliang Electronics Co., Ltd.

Cleared 2026-04-15

Registered with
  • US (FDA)
ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
Uni-C Cervical Cage System

ZheJiang Decans Medical Devices Co., Ltd.

Cleared 2026-04-15

Registered with
  • US (FDA)
CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076)

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
SureSmile Aligner (ASSY500020)

Dentsply Sirona

Cleared 2026-04-15

Registered with
  • US (FDA)
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD.

Cleared 2026-04-15

Registered with
  • US (FDA)
Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-04-15

Registered with
  • US (FDA)
REGEN Bioactive Cement

Inter-Med, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
OPRA Implant System

Integrum AB

Cleared 2026-04-15

Registered with
  • US (FDA)
  • AU (TGA)
Clearview 3

Lenstec, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes

Becton Dickinson and Company

Cleared 2026-04-15

Registered with
  • US (FDA)
Midas Restore

Sprintray, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

Biomet Orthopedics, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594); CapSure SP Z Lead, CapSure Z N

Medtronic Cardiac Rhythm Disease Management

Cleared 2026-04-15

Registered with
  • US (FDA)
Myocardial Pacing Lead

Medtronic, Inc

Cleared 2026-04-15

Registered with
  • US (FDA)
  • AU (TGA)
Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM

Lenstec, Inc.

Cleared 2026-04-15

Registered with
  • US (FDA)
STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Advanced Sterilization Products

Cleared 2026-04-15

Registered with
  • US (FDA)