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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
Sterile Latex Powder Free Surgical Gloves

Protect Gloves Co., Ltd.

Cleared 2026-05-22

Registered with
  • US (FDA)
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Genesee Biomedical, Inc.

Cleared 2026-05-22

Registered with
  • US (FDA)
DA VINCI FIREFLY IMAGING SYSTEM

Intuitive Surgical, Inc.

Cleared 2026-05-22

Registered with
  • US (FDA)
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Abbott Medical

Cleared 2026-05-22

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

Taizhou Huangyan Guanhong Plastic Steel Products Factory

Cleared 2026-05-22

Registered with
  • US (FDA)
Spectrum-2

Neko Health AB

Cleared 2026-05-22

Registered with
  • US (FDA)
  • UK (MHRA)
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)

Senzime AB

Cleared 2026-05-22

Registered with
  • US (FDA)
HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator

Philips Medical Systems, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Nisus NPWT Canister 500-mL (CPC-500)

CORK MEDICAL, LLC

Cleared 2026-05-21

Registered with
  • US (FDA)
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite

Wuhan United Imaging Healthcare Co., Ltd.

Cleared 2026-05-21

Registered with
  • US (FDA)
Boston 2910 (Boston 2910)

Boston Aesthetics, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

DCSTAR INC

Cleared 2026-05-21

Registered with
  • US (FDA)
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD

Cleared 2026-05-21

Registered with
  • US (FDA)
DCMhotbond zircon

Dental Creativ Management GmbH

Cleared 2026-05-21

Registered with
  • US (FDA)
Sphincterotome

Taewoong Medical Co., Ltd.

Cleared 2026-05-21

Registered with
  • US (FDA)
Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular Graft

Cook, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
ROSA® Shoulder System

Orthosoft Inc (D/B/A Zimmer Cas)

Cleared 2026-05-21

Registered with
  • US (FDA)
MuCover (proposed name) Oral Wound Dressing

MoleculeX Co., Ltd.

Cleared 2026-05-21

Registered with
  • US (FDA)
PanopticAI Vital Signs (1.6.1-22)

PanopticAI technologies Limited

Cleared 2026-05-21

Registered with
  • US (FDA)
Wearable Breast Pump (Model S39)

SHENZHEN TPH TECHNOLOGY CO., LTD.

Cleared 2026-05-21

Registered with
  • US (FDA)
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)

Olympus Medical Systems Corporation

Cleared 2026-05-21

Registered with
  • US (FDA)
MSK Go

Smart Alfa Teknoloji San. VE Tic. A.S.

Cleared 2026-05-21

Registered with
  • US (FDA)
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

Dragerwerk AG & Co KGaA

Cleared 2026-05-21

Registered with
  • US (FDA)
HeartStart FRx Defibrillator (861304)

Philips Medical Systems, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
Manual Wheelchair (DY01903(2))

GUANGDONG DAYANG MEDICAL TECHNOLOGY CO., LTD.

Cleared 2026-05-21

Registered with
  • US (FDA)
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

Hlb Lifescience Co., Ltd.

Cleared 2026-05-21

Registered with
  • US (FDA)
Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

Siemens Medical Solutions USA, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
pjur NATURE Touch, 100 ml

Pjur Group Luxembourg S.A.

Cleared 2026-05-21

Registered with
  • US (FDA)
Zenith Fenestrated AAA Endovascular Graft

William Cook Europe Aps

Cleared 2026-05-21

Registered with
  • US (FDA)
BAC

DeepHealth, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
ULTHERA SYSTEM

Ulthera, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
  • AU (TGA)
Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System

Cook, Medical

Cleared 2026-05-21

Registered with
  • US (FDA)
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Sofradim Production

Cleared 2026-05-21

Registered with
  • US (FDA)
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses

Pegavision Corporation

Cleared 2026-05-21

Registered with
  • US (FDA)
Shield

Guardant Health, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
DeepView AI® System

Spectralmd, Inc.

Cleared 2026-05-21

Registered with
  • US (FDA)
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Medtronic Vascular

Cleared 2026-05-21

Registered with
  • US (FDA)
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,

Olympus Winter &Ibe GmbH

Cleared 2026-05-21

Registered with
  • US (FDA)
MAASTRO Rectal Applicator Set

Varian Medical Systems inc

Cleared 2026-05-20

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
Aquilion ONE (TSX-308A/TSX-306A) V2.0

Canon Medical Systems Corporation

Cleared 2026-05-20

Registered with
  • US (FDA)
Derma-2

Neko Health AB

Cleared 2026-05-20

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

Suzhou Zenith Vascular SciTech Limited

Cleared 2026-05-20

Registered with
  • US (FDA)
WAVE PTA Balloon Catheter

WAVE Medical AG

Cleared 2026-05-20

Registered with
  • US (FDA)
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

Microport Neurotech (Shanghai) Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)
Elos Accurate® Denture Fixation System

Elos Medtech Pinol A/S

Cleared 2026-05-20

Registered with
  • US (FDA)
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

Lagis Enterprise Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)
Mobility Scooter (Air Carbon)

Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)
Blood Pressure Monitor (W06LT)

Shenzhen Jamr Technology Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)

Shenzhen Xiazhifeng Electronic Co., Ltd.

Cleared 2026-05-20

Registered with
  • US (FDA)