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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.

3,659 devices · when each source was last refreshed

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

Device
4K Camera Head OLYMPUS CH-S700-08-LB

Olympus Medical Systems Corporation

Cleared 2026-09-10

Registered with
  • US (FDA)
Symplicity Spyral™ Renal Denervation Catheter

Medtronic, Inc

Cleared 2026-09-10

Registered with
  • US (FDA)
  • UK (MHRA)
Belotero Volume (+) Lidocaine

Merz North America, Inc.

Cleared 2026-09-10

Registered with
  • US (FDA)
danumed Extension Set for Gastrostomy Button

Danumed Medizintechnik GmbH

Cleared 2026-09-10

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)

Guangzhou Red Pine Medical Instrument Co, Ltd

Cleared 2026-09-09

Registered with
  • US (FDA)
TOPS™ System

Premia Spine, Ltd.

Cleared 2026-09-09

Registered with
  • US (FDA)
  • AU (TGA)
ChestView US (1.1)

Gleamer

Cleared 2026-09-09

Registered with
  • US (FDA)
SQUID Liquid Embolic Agent (LEA)

Balt USA, LLC

Cleared 2026-09-09

Registered with
  • US (FDA)
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim

Top Glove Sdn. Bhd.

Cleared 2026-09-09

Registered with
  • US (FDA)
QF10

E.A.M Benelux B.V

Cleared 2026-09-09

Registered with
  • US (FDA)
eCoin implanted tibial stimulator

Boston Scientific Corp

Cleared 2026-09-09

Registered with
  • US (FDA)
prodisc® C

Centinel Spine

Cleared 2026-09-09

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

Maxter Healthcare, Inc.

Cleared 2026-09-09

Registered with
  • US (FDA)
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)

EndoClot Plus Co, Ltd

Cleared 2026-09-09

Registered with
  • US (FDA)
ReVISION 2

Argus Cognitive, Inc.

Cleared 2026-09-09

Registered with
  • US (FDA)
ColActive Plus

COVALON TECHNOLOGIES, INC.

Cleared 2026-09-09

Registered with
  • US (FDA)
da Vinci Surgical System, Model IS5000

Intuitive Surgical, Inc.

Cleared 2026-09-08

Registered with
  • US (FDA)
N22 Offset Humeral Head

Shoulder Innovations, LLC

Cleared 2026-09-08

Registered with
  • US (FDA)
Power Wheelchair (OS-R-M01I)

Beijing OrionStar Technology Co, Ltd

Cleared 2026-09-08

Registered with
  • US (FDA)
LANDMARK Total Knee System

Smith & Nephew, Inc.

Cleared 2026-09-08

Registered with
  • US (FDA)
LiteSet Trays

Nobel Biocare AB

Cleared 2026-09-08

Registered with
  • US (FDA)
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H

Drtech Corp.

Cleared 2026-09-08

Registered with
  • US (FDA)
MODI System

DreaMed Diabetes, Ltd.

Cleared 2026-09-08

Registered with
  • US (FDA)
Reusable SmartPeg

Osstell AB

Cleared 2026-09-08

Registered with
  • US (FDA)
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

B-One Ortho, Corp.

Cleared 2026-09-08

Registered with
  • US (FDA)
Emboliner Embolic Protection System (EPC-03)

Emboline, Inc.

Cleared 2026-09-08

Registered with
  • US (FDA)
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)

Zhejiang Geyi Medical Instrument Co, Ltd

Cleared 2026-09-08

Registered with
  • US (FDA)
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)

Medtronic, Inc

Cleared 2026-09-08

Registered with
  • US (FDA)
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

GMP MEDICARE SDN. BHD.

Cleared 2026-09-08

Registered with
  • US (FDA)
Dental Barriers and Sleeves (AB0006)

ANI Co., Ltd.

Cleared 2026-09-08

Registered with
  • US (FDA)
Electric wheelchair (HC819N, HC830N, HC831N)

Yongkang Hengyi Vehicle Co, Ltd

Cleared 2026-09-08

Registered with
  • US (FDA)
Thoraflex™ Hybrid

Vascutek, Ltd.

Cleared 2026-09-08

Registered with
  • US (FDA)
  • UK (MHRA)
ColoSense®

Geneoscopy, Inc.

Cleared 2026-09-08

Registered with
  • US (FDA)
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

Shenzhen OSTO Medical Technology Company Limited

Cleared 2026-09-06

Registered with
  • US (FDA)
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

Fidelity BioPharma Co.

Cleared 2026-09-06

Registered with
  • US (FDA)
LipoSurg ARTIST

NOUVAG AG

Cleared 2026-09-05

Registered with
  • US (FDA)
FreezeSpray TA

CRYOSURGERY, INC.

Cleared 2026-09-05

Registered with
  • US (FDA)
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Cleared 2026-09-04

Registered with
  • US (FDA)
NeoPEX™ Pre-Mixed Obturation Paste

NuSmile, Ltd.

Cleared 2026-09-04

Registered with
  • US (FDA)
FCT iStream Phase 2

FUJIFILM Corporation

Cleared 2026-09-04

Registered with
  • US (FDA)
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)

Cleared 2026-09-04

Registered with
  • US (FDA)
ActivaScrew™ Cannulated COM

Bioretec Ltd

Cleared 2026-09-04

Registered with
  • US (FDA)
GEL-ONE(R)

Seikagaku Corp.

Cleared 2026-09-04

Registered with
  • US (FDA)
SURGIKOS ARTIGRAFT

Lemaitre Vascular, Inc.

Cleared 2026-09-04

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

Medtronic Xomed

Cleared 2026-09-04

Registered with
  • US (FDA)
KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O

Cleared 2026-09-04

Registered with
  • US (FDA)
ATTUNE Revision Knee System

DePuy Orthopaedics, Inc.

Cleared 2026-09-04

Registered with
  • US (FDA)
Surgical and Prosthetic Trays

Dentsply Sirona

Cleared 2026-09-04

Registered with
  • US (FDA)
3D-RD-S

Radiopharmaceutical Imaging and Dosimetry, LLC

Cleared 2026-09-04

Registered with
  • US (FDA)
  • UK (MHRA)
Gastric Alimetry

Alimetry , Ltd.

Cleared 2026-09-04

Registered with
  • US (FDA)