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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
Tendyne™ Transcatheter Mitral Valve

Abbott Medical

Cleared 2025-10-04

Registered with
  • US (FDA)
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

Internacional Farmaceutica, S.A. DE C.V.

Cleared 2025-10-03

Registered with
  • US (FDA)
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)

Shanghai AnQing Medical Instrument Co., Ltd.

Cleared 2025-10-03

Registered with
  • US (FDA)
HPACS

Healthhub

Cleared 2025-10-03

Registered with
  • US (FDA)
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Olympus Medical Systems Corporation

Cleared 2025-10-03

Registered with
  • US (FDA)
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

Jeisys Medical, Inc.

Cleared 2025-10-03

Registered with
  • US (FDA)
ProSense™ System

ICECURE MEDICAL LTD.

Cleared 2025-10-03

Registered with
  • US (FDA)
AETOS Shoulder System Stemless Humeral Prosthesis

Smith & Nephew, Inc.

Cleared 2025-10-03

Registered with
  • US (FDA)
Anti Snore Mouthpiece

Dongguan Yiyao Science & Technology Development Co., Ltd

Cleared 2025-10-03

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
HESTIA (L200-A)

Senbitec Co., Ltd.

Cleared 2025-10-03

Registered with
  • US (FDA)
xvision Spine System

Augmedics, Ltd.

Cleared 2025-10-03

Registered with
  • US (FDA)
extriCARE® 1000 Negative Pressure Wound Therapy System

Alleva Medical Devices

Cleared 2025-10-03

Registered with
  • US (FDA)
Bunkerhill MAC

Bunkerhill Health

Cleared 2025-10-03

Registered with
  • US (FDA)
Amplatzer Guidewire

Abbott Medical

Cleared 2025-10-03

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)

Hollister, Inc.

Cleared 2025-10-03

Registered with
  • US (FDA)
Revolve Surgical System

Revolve Surgical, Inc.

Cleared 2025-10-03

Registered with
  • US (FDA)
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

Tosoh Bioscience, Inc.

Cleared 2025-10-03

Registered with
  • US (FDA)
PROVSIC™ Ophthalmic Viscosurgical Device

Alcon Research, Ltd.

Cleared 2025-10-03

Registered with
  • US (FDA)
Manual Wheelchair (SYIV100A008)

Ningbo Shenyu Medical Equipment Co, Ltd

Cleared 2025-10-03

Registered with
  • US (FDA)
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)

Shenzhen Sophway Technology Co.,Ltd.

Cleared 2025-10-02

Registered with
  • US (FDA)
Cannulated Screw and Kirschner (K wire) System

Orthonovis, Inc.

Cleared 2025-10-02

Registered with
  • US (FDA)
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

Artivion, Inc.

Cleared 2025-10-02

Registered with
  • US (FDA)
G-Bond Universal

GC AMERICA INC.

Cleared 2025-10-02

Registered with
  • US (FDA)
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)

Simergent, LLC

Cleared 2025-10-02

Registered with
  • US (FDA)
BreatheBand® (Model 1000)

Exemplar Medical, LLC

Cleared 2025-10-02

Registered with
  • US (FDA)
LungQ 4

Thirona Corporation

Cleared 2025-10-02

Registered with
  • US (FDA)
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Liofilchem S. R. L.

Cleared 2025-10-02

Registered with
  • US (FDA)
IPL Hair Removal Device (IPL-001, IPL-002)

Shenzhen ENMIND Technology Co, Ltd

Cleared 2025-10-02

Registered with
  • US (FDA)
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Ningbo Tianyi Medical Appliance Co., Ltd.

Cleared 2025-10-02

Registered with
  • US (FDA)
Philips IntelliSpace Cardiovascular

Philips Medical Systems Nederland BV

Cleared 2025-10-02

Registered with
  • US (FDA)
EasyTeleMed (2.0.2)

Ingeniars S.R.L.

Cleared 2025-10-02

Registered with
  • US (FDA)
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device

Applied Medical Resources

Cleared 2025-10-02

Registered with
  • US (FDA)
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)

Shenzhen Finicare Co., Ltd.

Cleared 2025-10-02

Registered with
  • US (FDA)
E Blator

NEW DEANTRONICS TAIWAN LTD.

Cleared 2025-10-01

Registered with
  • US (FDA)
Picosecond laser device (BMPS4)

Hebei Newangie Technology Co., Ltd.

Cleared 2025-10-01

Registered with
  • US (FDA)
PRO-DOSE System

Nu-Rise, SA

Cleared 2025-10-01

Registered with
  • US (FDA)
Visby Medical Men's Sexual Health Test

Visby Medical

Cleared 2025-10-01

Registered with
  • US (FDA)
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)

SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD

Cleared 2025-10-01

Registered with
  • US (FDA)
Light Therapy Decollete Mask (1019135)

Merchsource, LLC

Cleared 2025-10-01

Registered with
  • US (FDA)
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,

SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD

Cleared 2025-10-01

Registered with
  • US (FDA)
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)

Wuxi Hisky Medical Technologies Co., Ltd.

Cleared 2025-10-01

Registered with
  • US (FDA)
Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics S.A.S

Cleared 2025-10-01

Registered with
  • US (FDA)
Astrasono A3Pro Bladder Scanner (A3Pro)

Astrasono Technology Co., Ltd.

Cleared 2025-09-30

Registered with
  • US (FDA)
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)

Wright Medical Technology, Inc. (Stryker)

Cleared 2025-09-30

Registered with
  • US (FDA)
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter

Shanghai Draeger Medical Instrument Co., Ltd.

Cleared 2025-09-30

Registered with
  • US (FDA)
Biopsy Forceps

FEHLING INSTRUMENTS GmbH

Cleared 2025-09-30

Registered with
  • US (FDA)
Arthrex SpeedFLEX™ Implant

Arthrex, Inc.

Cleared 2025-09-30

Registered with
  • US (FDA)
Akreos Posterior Chamber Intraocular Lens (IOL)

Bausch & Lomb Incorporated

Cleared 2025-09-30

Registered with
  • US (FDA)
TigerConnect Alarm Management

Tigerconnect

Cleared 2025-09-30

Registered with
  • US (FDA)
Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)

Jiangsu Bangbang Intelligent Technology Co., Ltd.

Cleared 2025-09-30

Registered with
  • US (FDA)