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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
Ceribell Brain Monitor Headband

Ceribell, Inc.

Cleared 2026-04-03

Registered with
  • US (FDA)
ClearCheck (RADCC V2.7)

Radformation

Cleared 2026-04-03

Registered with
  • US (FDA)
LSSA (NP-200)

Newpong Co Ltd

Cleared 2026-04-03

Registered with
  • US (FDA)
neuropacs

Automated Imaging Diagnostics, LLC

Cleared 2026-04-03

Registered with
  • US (FDA)
Single-use Video Scope; PB Digital Controller

Mirco-Tech (Nanjing) Co., Ltd.

Cleared 2026-04-03

Registered with
  • US (FDA)
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

Med-El Elektromedizinische Geräte GmbH

Cleared 2026-04-03

Registered with
  • US (FDA)
HYALEX® MTP Hemiarthroplasty Implant

Hyalex Orthopaedics, Inc.

Cleared 2026-04-03

Registered with
  • US (FDA)
Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear

Euclid Vision Corporation

Cleared 2026-04-02

Registered with
  • US (FDA)
FLASH Flex™ Aorto-Ostial Angioplasty System

Verge Medical, Inc.

Cleared 2026-04-02

Registered with
  • US (FDA)
Tahoe Unicondylar Knee System with TiNbN Overcoat

Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics

Cleared 2026-04-02

Registered with
  • US (FDA)
LifeShield™ Infusion Safety Software Suite

ICU Medical, Inc

Cleared 2026-04-02

Registered with
  • US (FDA)
  • Canada (Health Canada)
Disposable Infusion Bag for Parenteral Nutrition

Beijing L&Z Medical Technology Development Co, Ltd

Cleared 2026-04-02

Registered with
  • US (FDA)
Cryopush Cold Compression Device (A02-P-001)

Chengdu Cryo-Push Medical Technology Co.,Ltd

Cleared 2026-04-02

Registered with
  • US (FDA)
SMART M-CELL Bone Marrow Concentration System

Miracell Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
SMART M-CELL PRP Concentration System

Miracell Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
Embrace Hydrogel Embolic System (HES)

Instylla, Inc.

Cleared 2026-04-02

Registered with
  • US (FDA)
BELLIGER ACE

Genoray Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
  • EU (EUDAMED)
Tina-quant Cardiac high sensitivity CRP III

Roche Diagnostics GmbH

Cleared 2026-04-02

Registered with
  • US (FDA)
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)

Medical Brands Laboratories B.V.

Cleared 2026-04-02

Registered with
  • US (FDA)
SPECCHIO

EL.EN. S.P.A.

Cleared 2026-04-02

Registered with
  • US (FDA)
Onclarity™ Self-Collection Kit

Becton Dickinson and Company

Cleared 2026-04-02

Registered with
  • US (FDA)
Leforte MMF System

JEIL MEDICAL CORPORATION

Cleared 2026-04-02

Registered with
  • US (FDA)
Wireless Probe Type Ultrasound Scanner

Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Cleared 2026-04-02

Registered with
  • US (FDA)
  • EU (EUDAMED)
BD Insyte™ IV Catheter

Becton Dickinson Infusion Therapy Systems, Inc.

Cleared 2026-04-02

Registered with
  • US (FDA)
  • UK (MHRA)
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

ConvaTec Limited

Cleared 2026-04-01

Registered with
  • US (FDA)
RM Electrode (RMH 25-01)

Retmap, Inc.

Cleared 2026-04-01

Registered with
  • US (FDA)
Synchrony

Stereotaxis, Inc.

Cleared 2026-04-01

Registered with
  • US (FDA)
  • EU (EUDAMED)
SpineSeal Spine Sealant

Pramand, LLC

Cleared 2026-04-01

Registered with
  • US (FDA)
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)

Shenzhen HanHan Technology Co., Ltd.

Cleared 2026-04-01

Registered with
  • US (FDA)
MOD-C

Orthomod, LLC

Cleared 2026-04-01

Registered with
  • US (FDA)
Impella RP System, Impella RP with Smart Assist System, Impella RP Flex System

Abiomed, Inc.

Cleared 2026-04-01

Registered with
  • US (FDA)
enHAnce PEEK Bunion System

Nvision Biomedical Technologies, LLC

Cleared 2026-04-01

Registered with
  • US (FDA)
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)

Poly Medicure Limited

Cleared 2026-04-01

Registered with
  • US (FDA)
Medical Imaging Calibration Feature (MICF)

Apple, Inc.

Cleared 2026-04-01

Registered with
  • US (FDA)
CoLumbo C-Spine

Smart Soft Healthcare AD

Cleared 2026-04-01

Registered with
  • US (FDA)
DIAM­™ Spinal Stabilization System

Companion Spine France SAS

Cleared 2026-04-01

Registered with
  • US (FDA)
Prana System

Prana Surgical

Cleared 2026-04-01

Registered with
  • US (FDA)
Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

Hudi Pharma Srl

Cleared 2026-04-01

Registered with
  • US (FDA)
GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

Shenzhen RF Tech Co., Ltd.

Cleared 2026-04-01

Registered with
  • US (FDA)
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro

Shenzhen Aoj Medical Technology Co., Ltd.

Cleared 2026-04-01

Registered with
  • US (FDA)
Safety lancet (XXXVII)

Tianjin Huahong Technology Co, Ltd

Cleared 2026-03-31

Registered with
  • US (FDA)
Nd: YAG Laser Therapy Systems

Sanhe Meditech Co.,Ltd

Cleared 2026-03-31

Registered with
  • US (FDA)
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

Vatech Co., Ltd.

Cleared 2026-03-31

Registered with
  • US (FDA)
K5 wheelchair (16" with swing-away footrest 18" with swing-away footrest 20" with swing-away footrest 16" with elevated foot rest(ELR) 18" with elevated foot rest(ELR) 20" with elevated foot rest(ELR))

Zhenjiang Assure Medical Equipment Co., Ltd.

Cleared 2026-03-31

Registered with
  • US (FDA)
RW-1

Mediott, Inc.

Cleared 2026-03-31

Registered with
  • US (FDA)
InjecSURE Injection System

Carbon Medical Technologies, Inc.

Cleared 2026-03-31

Registered with
  • US (FDA)
FINDER Flu A&B/SARS-CoV-2 Test

Baebies, Inc.

Cleared 2026-03-30

Registered with
  • US (FDA)
Avatar Medical Vision

Avatar Medical

Cleared 2026-03-30

Registered with
  • US (FDA)
  • EU (EUDAMED)
implantcast Packaging System Update

Implantcast GmbH

Cleared 2026-03-30

Registered with
  • US (FDA)
Francisella tularensis Real-time PCR assay

Centers For Disease Control and Prevention

Cleared 2026-03-30

Registered with
  • US (FDA)