Search FDA 510(k) Devices

5,518 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
2809–2832 of 174,061
Cleared May 14, 2025
Helios Dura Regeneration Matrix
K250420 · GXQ
Helios Biomedical, Inc.
Neurology · 90d
Cleared May 14, 2025
CaloPix
K250414 · QKQ
Tribun Health
Pathology · 90d
Cleared May 14, 2025
Nerivio
K250405 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 90d
Cleared May 14, 2025
Medical Picosecond ND: YAG Laser System (PZ-6)
K250041 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 126d
Cleared May 14, 2025
Disposable ureteral stent
K243830 · FAD
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 152d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 14, 2025
Smile Dx®
K242437 · MYN
Cube Click, Inc.
Radiology · 271d
Cleared May 14, 2025
CeraRoot TL Implant System (TL)
K242072 · DZE
Ceraroot SL
Dental · 302d
Cleared May 13, 2025
Promisemed Safety Huber Needles
K251138 · PTI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 29d
Cleared May 13, 2025
SP Endoscope, 0° (430600)
K250786 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 60d
Cleared May 13, 2025
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
K250418 · OHV
Ulthera, Inc.
General & Plastic Surgery · 89d
Cleared May 13, 2025
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
K242808 · IYN
Canon Medical Systems Corporation
Radiology · 238d
Cleared May 13, 2025
Aesculap Aicon® Series Container System
K242762 · KCT
Aesculap, Inc.
General Hospital · 243d
Cleared May 13, 2025
Freedom Posterior Cervical Screws
K242674 · NKG
Signature Orthopaedics Pty, Ltd.
Orthopedic · 249d
Cleared May 12, 2025
SPECTRALIS HRA+OCT and variants
K250868 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 49d
Cleared May 12, 2025
Reon
K250763 · EBF
C.E.I.B.Med
Dental · 60d
Cleared May 12, 2025
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
K250592 · OWQ
Northeast Scientific, Inc.
Cardiovascular · 74d
Cleared May 12, 2025
Medical Diode Laser Hair Removal System (MNLT-D1)
K250431 · GEX
Shandong Moonlight Electronics Tech...
General & Plastic Surgery · 87d
Cleared May 12, 2025
InThrill™ Thrombectomy System
K250421 · QEW
Inari Medical, Inc.
Cardiovascular · 88d
Cleared May 12, 2025
ZircaGlow & ZircaGlow HT Zirconia
K250393 · EIH
United Zirconia
Dental · 89d
Cleared May 12, 2025
AYON Body Contouring System (AYON SYSTEM)
K244050 · QPB
Apyx Medical Corporation
General & Plastic Surgery · 132d
Cleared May 12, 2025
uWS-Angio Basic
K243632 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 168d
Cleared May 12, 2025
Archer PSI System
K243509 · QHE
3D-Side
Orthopedic · 181d
Cleared May 12, 2025
Shoulder Soft Tissue Anchors
K242477 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 264d