Search FDA 510(k) Devices

5,418 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
793–816 of 3,225
Cleared Oct 02, 2025
LungQ 4
K250766 · JAK
Thirona BV
Radiology · 203d
Cleared Oct 02, 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K250551 · GCJ
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 219d
Cleared Oct 02, 2025
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)
K250523 · FKX
Simergent, LLC
Gastroenterology & Urology · 223d
Cleared Oct 02, 2025
GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
K243152 · HEW
Applied Medical Resources Corp.
Obstetrics & Gynecology · 367d
Cleared Oct 01, 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP,...
K252804 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Oct 01, 2025
Picosecond laser device (BMPS4)
K252447 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Oct 01, 2025
Light Therapy Decollete Mask (1019135)
K252096 · OHS
Merchsource, LLC
General & Plastic Surgery · 90d
Cleared Oct 01, 2025
E Blator
K251899 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 103d
Cleared Oct 01, 2025
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
K251825 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 110d
Cleared Oct 01, 2025
Vena MicroAngioscope™ System
K251767 · LYK
Vena Medical Holdings Corp
Cardiovascular · 113d
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Visby Medical, Inc.
Microbiology · 139d
Cleared Oct 01, 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · PBF
Newclip Technics
Orthopedic · 202d
Cleared Oct 01, 2025
PRO-DOSE System
K250083 · NZT
Nu-Rise, SA
Radiology · 261d
Cleared Oct 01, 2025
Shear Wave Quantificational Ultrasound Diagnostic System...
K250026 · IYN
Wuxi Hisky Medical Technologies Co.,...
Radiology · 268d
Cleared Sep 30, 2025
Biopsy Forceps
K252722 · DWZ
Fehling Instruments GmbH
Cardiovascular · 33d
Cleared Sep 30, 2025
External Fixation Mini Rail System
K252106 · KTT
Paragon 28, Inc.
Orthopedic · 89d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
Cleared Sep 30, 2025
Francisella tularensis Real-time PCR assay
K252072 · SGA
Centers For Disease Control and...
Microbiology · 91d
Cleared Sep 30, 2025
Mobility Scooter (BBR-Q40-01)
K251799 · INI
Jiangsu Bangbang Intelligent...
Physical Medicine · 110d
Cleared Sep 30, 2025
Arthrex SpeedFLEX™ Implant
K251690 · OWY
Arthrex, Inc.
Orthopedic · 120d
Cleared Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · DSA
Shanghai Draeger Medical Instrument...
Cardiovascular · 123d
Cleared Sep 30, 2025
Dexter L6 System
K251197 · SDD
Distalmotion SA
General & Plastic Surgery · 166d
Cleared Sep 30, 2025
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · IYO
Astrasono Technology Co., Ltd.
Radiology · 237d
Cleared Sep 30, 2025
miDiagnostics HSV-1&2 CSF Test
K250050 · PGH
Midiagnostics NV
Microbiology · 263d