Search FDA 510(k) Devices

5,430 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
985–1008 of 3,225
Cleared Sep 11, 2025
Vivatmo pro-S
K243926 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 265d
Cleared Sep 11, 2025
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
K242314 · LLZ
Augment Intelligent Medical System...
Radiology · 402d
Cleared Sep 10, 2025
iQ200 Series
K252580 · LKM
Beckman Coulter, Inc.
Hematology · 26d
Cleared Sep 10, 2025
OptiVu™ Shoulder
K252530 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 30d
Cleared Sep 10, 2025
Surfacer Inside-Out Access Catheter System
K252527 · QJH
Merit Medical System, Inc.
Cardiovascular · 30d
Cleared Sep 10, 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb...
K252173 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 61d
Cleared Sep 10, 2025
da Vinci SP Surgical System (SP1098)
K251817 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 10, 2025
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573 · LPL
Vizionfocus, Inc.
Ophthalmic · 111d
Cleared Sep 10, 2025
OptiLUV Device
K250734 · PBX
Pollogen, Ltd.
General & Plastic Surgery · 183d
Cleared Sep 10, 2025
Enlight 2100 (TPL-E2103-0)
K250464 · QEB
Timpel S.A.
Anesthesiology · 204d
Cleared Sep 10, 2025
AngioWaveNet
K244002 · QIH
Angiowave Imaging, Inc.
Radiology · 258d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Sep 09, 2025
Quadsense (Quadsense and Quadsense Pro)
K252524 · ONN
Eventum Orthopaedics, Ltd.
Orthopedic · 29d
Cleared Sep 09, 2025
Hybrid Viewer (00859873006240)
K252477 · KPS
Hermes Medical Solutions AB
Radiology · 33d
Cleared Sep 09, 2025
AquaA
K252181 · FIP
Fresenius Medical Care North America
Gastroenterology & Urology · 60d
Cleared Sep 09, 2025
Bicarby Dialysate RFP-404 (RFP-404-W)
K252180 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 60d
Cleared Sep 09, 2025
Electric Wheelchair (GY-E001)
K251891 · ITI
Shandong Guyue Healthcare Appliance...
Physical Medicine · 81d
Cleared Sep 09, 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
K251773 · NUC
Shenzhen Yongquan Medical Devices...
Obstetrics & Gynecology · 91d
Cleared Sep 09, 2025
MuscleView 2.0
K251682 · LNH
Springbok, Inc. (Dba Springbok...
Radiology · 102d
Cleared Sep 09, 2025
Segmentron Viewer
K251072 · QIH
DGNCT, LLC
Radiology · 155d
Cleared Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
K251040 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 159d
Cleared Sep 09, 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922 · DSB
Cardioset Medical , Ltd.
Cardiovascular · 166d
Cleared Sep 09, 2025
PhotonBlade 3
K250483 · GEI
Stryker Instruments
Cardiovascular · 202d
Cleared Sep 09, 2025
Access anti-HAV
K243846 · LOL
Beckman Coulter, Inc.
Microbiology · 267d