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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
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)
External Fixation Mini Rail System

Paragon 28, Inc

Cleared 2025-09-30

Registered with
  • US (FDA)
miDiagnostics HSV-1&2 CSF Test

Midiagnostics NV

Cleared 2025-09-30

Registered with
  • US (FDA)
PALTOP DENTAL IMPLANT SYSTEM

Paltop Advanced Dental Solutions, Ltd.

Cleared 2025-09-29

Registered with
  • US (FDA)
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)

Hager & Meisinger GmbH

Cleared 2025-09-29

Registered with
  • US (FDA)
SMART PCFD

Disior, Ltd.

Cleared 2025-09-29

Registered with
  • US (FDA)
UltraGuideCTR® image guided soft tissue release system

Sonex Health, Inc.

Cleared 2025-09-29

Registered with
  • US (FDA)
G-BLOCK

Graphenano Dental S.L.

Cleared 2025-09-29

Registered with
  • US (FDA)
LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT

Bard Peripheral Vascular Inc

Cleared 2025-09-29

Registered with
  • US (FDA)
Portable oxygen concentrator (JAY-1000P)

Longfian Scitech Co., Ltd.

Cleared 2025-09-29

Registered with
  • US (FDA)
SureTome™ SW Sphincterotome with DomeTip®

Wilson-Cook Medical, Inc.

Cleared 2025-09-29

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Primero Safe Access System

South53, LLC

Cleared 2025-09-29

Registered with
  • US (FDA)
SpineAR SNAP (SyncAR Spine)

Surgical Theater, LLC

Cleared 2025-09-29

Registered with
  • US (FDA)
NEW DOUBLO 2.0

Hironic Co., Ltd.

Cleared 2025-09-29

Registered with
  • US (FDA)
allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

Tulavi Therapeutics

Cleared 2025-09-29

Registered with
  • US (FDA)
AUXILIARY WATER TUBE MAJ-855

Olympus Medical Systems Corporation

Cleared 2025-09-26

Registered with
  • US (FDA)
LoFric Origo

Wellspect AB

Cleared 2025-09-26

Registered with
  • US (FDA)
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS

Boston Scientific Corp

Cleared 2025-09-26

Registered with
  • US (FDA)
Optima Coil System (Optima Packing Coil System)

Balt USA, LLC

Cleared 2025-09-26

Registered with
  • US (FDA)
  • AU (TGA)
FUJIFILM Stiffening Wire Device (SW-2000)

Fujifilm Healthcare Americas Corporation

Cleared 2025-09-26

Registered with
  • US (FDA)
Tuned Self-Fitting Mobile App

Tuned , Ltd.

Cleared 2025-09-26

Registered with
  • US (FDA)