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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.

3,665 devices · when each source was last refreshed

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

Device
ASCENSION ORTHOPEDICS MCP

Smith & Nephew, Inc.

Cleared 2025-12-31

Registered with
  • US (FDA)
MOLLI 2 System

Stryker Endoscopy

Cleared 2025-12-31

Registered with
  • US (FDA)
Proliv™Rx System

Neurolief , Ltd.

Cleared 2025-12-31

Registered with
  • US (FDA)
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

Arc Trauma, LLC

Cleared 2025-12-31

Registered with
  • US (FDA)
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Shenzhen Jiantuo Electronics Co., Ltd.

Cleared 2025-12-31

Registered with
  • US (FDA)
Lipids

Truvian Health

Cleared 2025-12-30

Registered with
  • US (FDA)
AnyScan 3.0 NM Scanner Family

Mediso Medical Imaging Systems Ltd

Cleared 2025-12-30

Registered with
  • US (FDA)
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

Lucas Lifecare

Cleared 2025-12-30

Registered with
  • US (FDA)
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

Arthrex, Inc.

Cleared 2025-12-30

Registered with
  • US (FDA)
TruSPECT Processing Station

Spectrum Dynamics Medical, Ltd.

Cleared 2025-12-30

Registered with
  • US (FDA)
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

TECHNO-PATH MANUFACTURING LTD.

Cleared 2025-12-30

Registered with
  • US (FDA)
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)
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)
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)