Search FDA 510(k) Devices

5,486 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
1921–1944 of 3,225
Cleared May 30, 2025
5008X Hemodialysis System
K243505 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 199d
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 246d
Cleared May 30, 2025
AudaxCeph Cephalogram Analysis Software
K243005 · QIH
Audax D.O.O.
Radiology · 246d
Cleared May 30, 2025
XBody Go USA, XBody Pro USA
K242926 · NGX
Xbody Hungary Kft.
Physical Medicine · 248d
Cleared May 30, 2025
LensHooke X3 PRO Semen Quality Analyzer
K242830 · POV
Bonraybio Co., Ltd.
Hematology · 253d
Cleared May 30, 2025
ARIX Pectus Bar System
K242751 · HRS
Jeil Medical Corporation
Orthopedic · 260d
Cleared May 30, 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and...
K242725 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 262d
Cleared May 30, 2025
FertiCult Flushing medium
K242640 · MQL
Fertipro NV
Obstetrics & Gynecology · 269d
Cleared May 30, 2025
Endoscopic Distal Attachment (AF-D series)
K242635 · FDS
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 269d
Cleared May 30, 2025
OHC COVID-19 Antigen Self Test
K241313 · QYT
Osang, LLC
Microbiology · 386d
Not Cleared May 30, 2025
Allix5
DEN240047 · SEZ
Clairity, Inc.
Radiology · 266d
Cleared May 29, 2025
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
K251340 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 29d
Cleared May 29, 2025
VersaCross Connect™ Transseptal Dilator
K251325 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared May 29, 2025
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation...
K251315 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared May 29, 2025
Radius VSM and Accessories
K250757 · MHX
Masimo Corporation
Cardiovascular · 78d
Cleared May 29, 2025
CERABIEN MiLai
K250673 · EIH
Kuraray Noritake Dental, Inc.
Dental · 84d
Cleared May 29, 2025
Dental Barrier and Sleeves
K250606 · PEM
Yueying Medical Instruments...
Dental · 90d
Cleared May 29, 2025
Voluson™ Performance 16
K250543 · IYN
GE Medical Systems Ultrasound and...
Radiology · 94d
Cleared May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · ONO
Medtronic Navigation
Neurology · 115d
Cleared May 29, 2025
Baha 7 Sound Processor
K250215 · LXB
Cochlear
Ear, Nose, Throat · 125d
Cleared May 29, 2025
NEUROMARK System (NMK00301)
K250048 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 139d
Cleared May 29, 2025
TENS AND EMS (TENS and Muscle Stimulator) ( Model...
K243856 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 164d
Cleared May 29, 2025
Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU,...
K243497 · EOQ
Shanghai AnQing Medical Instrument...
Ear, Nose, Throat · 198d
Cleared May 29, 2025
PM2+ System and SmartPICC Stylet
K243484 · LJS
Piccolo Medical, Inc.
Cardiovascular · 202d