Search FDA 510(k) Devices

5,446 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1585–1608 of 174,061
Cleared Sep 25, 2025
Hi bebe super (BT-150B)
K251512 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Sep 25, 2025
Root canal repair materials (nRoot BP)
K251465 · KIF
Enpuno Biotechnology Co., Ltd.
Dental · 135d
Cleared Sep 25, 2025
JDEvolution Plus L and JDEvolution Plus LE
K251148 · DZE
Jdentalcare Srl
Dental · 164d
Cleared Sep 25, 2025
Pulse Oximeter
K250837 · DQA
Shanghai Berry Electronic Tech Co., Ltd.
Anesthesiology · 189d
Cleared Sep 25, 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · OVE
Innovasis
Orthopedic · 258d
Cleared Sep 25, 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens...
K244009 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 273d
Cleared Sep 25, 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye...
K243785 · BTR
Covidien, LLC
Anesthesiology · 290d
Cleared Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
K252703 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Sep 24, 2025
MEDRAD Centargo CT Injection System
K252689 · IZQ
Imaxeon Pty, Ltd.
General Hospital · 29d
Cleared Sep 24, 2025
LenSx Laser System (8065000944)
K252682 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Sep 24, 2025
Celerity™ 20 HP Biological Indicator
K252680 · FRC
STERIS Corporation
General Hospital · 30d
Cleared Sep 24, 2025
Pounce(TM) Sheath
K252227 · DYB
Surmodics,Inc.
Cardiovascular · 70d
Cleared Sep 24, 2025
Resitu Slider 09 (RESL09)
K252183 · KNW
Resitu Medical AB
General & Plastic Surgery · 75d
Cleared Sep 24, 2025
ProVee Video Processing Unit (PV-003)
K251734 · FET
Proverum Limited
Gastroenterology & Urology · 110d
Cleared Sep 24, 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · MUH
Dentimax, Inc.
Radiology · 159d
Cleared Sep 24, 2025
t:slim X2 insulin pump with interoperable technology
K250792 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 194d
Cleared Sep 24, 2025
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
K250071 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 257d
Cleared Sep 24, 2025
uWS-Angio Pro
K250045 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 257d
Cleared Sep 24, 2025
ROBOPERA (ER-R-002)
K244029 · FDF
Endorobotics Co., Ltd.
Gastroenterology & Urology · 268d
Cleared Sep 24, 2025
Retraxil
K243910 · MVL
Kulzer, LLC
Dental · 279d
Cleared Sep 23, 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Sep 23, 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · NEW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 33d
Cleared Sep 23, 2025
Ion Endoluminal System (IF1000)
K252045 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 85d
Cleared Sep 23, 2025
Bipolar applicator CelonProBreath (WB990310)
K252043 · GEI
Olympus Winter & Ibe GmbH
Ear, Nose, Throat · 85d