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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
Celebrace Software

Celebrace

Cleared 2025-12-29

Registered with
  • US (FDA)
Oxygen Concentrator (J10A)

Foshan Kycare Medical Equipment Co., Ltd.

Cleared 2025-12-29

Registered with
  • US (FDA)
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

Covidien

Cleared 2025-12-29

Registered with
  • US (FDA)
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

Taewoong Medical Co., Ltd.

Cleared 2025-12-29

Registered with
  • US (FDA)
ZipToe™ Hammertoe Fusion System

Toetal Solutions

Cleared 2025-12-29

Registered with
  • US (FDA)
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT

Covidien

Cleared 2025-12-29

Registered with
  • US (FDA)
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

Shenzhen Fansizhe Science And Technology Co., Ltd.

Cleared 2025-12-29

Registered with
  • US (FDA)
PICO-K

Speclipse, Inc.

Cleared 2025-12-24

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
Hair Regrowth Cap (Model: T-119-HRC)

Light Tree Ventures Europe B.V.

Cleared 2025-12-24

Registered with
  • US (FDA)
LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

SHENZHEN SAIDI LIGHT THERAPY TECHNOLOGY CO., LTD

Cleared 2025-12-24

Registered with
  • US (FDA)
Feather/numiere 05 06 07 (05)

Heat IN A Click, LLC

Cleared 2025-12-24

Registered with
  • US (FDA)
LIAISON NES FLU A/B, RSV & COVID-19

DiaSorin Molecular LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
OsteoRemedies Hip Spacer System

Osteoremedies, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
UpDoc

Updoc, Inc.

Cleared 2025-12-23

Registered with
  • US (FDA)
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Biosense Webster, Inc.

Cleared 2025-12-23

Registered with
  • US (FDA)
Healgen URS Test Strips

Healgen Scientific, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
OrangeCAD Med Abutments

OrangeCAD Med GmbH

Cleared 2025-12-23

Registered with
  • US (FDA)
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Shenzhen Siken 3D Technology Development Co., Ltd.

Cleared 2025-12-23

Registered with
  • US (FDA)
AIR Recon DL

Ge Medical Systems, Inc.

Cleared 2025-12-23

Registered with
  • US (FDA)
Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.

Cleared 2025-12-23

Registered with
  • US (FDA)
Custom Abutments AS

Medentika GMBH

Cleared 2025-12-23

Registered with
  • US (FDA)
DUROLANE®

Bioventus, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
SYNOJOYNT

Mesoblast

Cleared 2025-12-23

Registered with
  • US (FDA)
GEN5™ and GEN5+™ 3.3mmD Dental Implants

Paragon Implant Mfg., LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
ART-Plan+ (v3.1.0)

Therapanacea

Cleared 2025-12-23

Registered with
  • US (FDA)
Philips Lumea IPL

Philips Consumer Lifestyle

Cleared 2025-12-23

Registered with
  • US (FDA)
LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)

DiaSorin, Inc.

Cleared 2025-12-23

Registered with
  • US (FDA)
NizPlant Dental Implant System

Paragon Implant Mfg., LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
UNITY DX (UDX)

Cylite Pty. , Ltd.

Cleared 2025-12-23

Registered with
  • US (FDA)
VarioSurg 4

NAKANISHI INC.

Cleared 2025-12-23

Registered with
  • US (FDA)
Electric Scooter (S202572J, S2060, M2089, S2050)

Guangdong Prestige Technology Co, Ltd

Cleared 2025-12-23

Registered with
  • US (FDA)
VEINOPLUS Back

Dynapulse Medical

Cleared 2025-12-23

Registered with
  • US (FDA)
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Hong Qiangxing (Shenzhen) Electronics Limited

Cleared 2025-12-23

Registered with
  • US (FDA)
Sim&Size

Sim&Cure

Cleared 2025-12-23

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
Aura Glide (FC40)

Aura Medical, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)

Hycor Biomedical, Inc.

Cleared 2025-12-23

Registered with
  • US (FDA)
LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)

Dongguan Yijiaming Technology Co., Ltd.

Cleared 2025-12-23

Registered with
  • US (FDA)
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

Healgen Scientific, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
Active-V Total Knee System; World Total Knee System

Signature Orthopaedics Pty Ltd

Cleared 2025-12-23

Registered with
  • US (FDA)
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

Edan Instruments, Inc

Cleared 2025-12-23

Registered with
  • US (FDA)
QIKCAP System

Hai Solutions

Cleared 2025-12-23

Registered with
  • US (FDA)
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

Medimaging Integrated Solution, Inc (Miis)

Cleared 2025-12-23

Registered with
  • US (FDA)
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)

Bruno Vision Care, LLC

Cleared 2025-12-23

Registered with
  • US (FDA)
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

Cleared 2025-12-23

Registered with
  • US (FDA)
Portable oxygen concentrator (JLO-190P)

Shenzhen Homed Medical Device Co, Ltd

Cleared 2025-12-22

Registered with
  • US (FDA)
BioticsAI

Bioticsai, Inc.

Cleared 2025-12-22

Registered with
  • US (FDA)
Oxygen Concentrator-P2-O5E

Qingdao Kingon Medical Science and Technology Co.

Cleared 2025-12-22

Registered with
  • US (FDA)
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

Bioteque Corp.

Cleared 2025-12-22

Registered with
  • US (FDA)
InnoClip Disposable Clip Applier

Taiwan Surgical Corporation

Cleared 2025-12-22

Registered with
  • US (FDA)
Inspire HCR and HCR DUAL cardiotomy reservoirs

Sorin Group Italia S.R.L.

Cleared 2025-12-22

Registered with
  • US (FDA)