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
769–792 of 3,225
Cleared Oct 03, 2025
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K251859 · ODG
Olympus Medical Systems Corporation
Gastroenterology & Urology · 108d
Cleared Oct 03, 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · OMP
Alleva Medical Devices
General & Plastic Surgery · 127d
Cleared Oct 03, 2025
xvision Spine system
K251639 · SBF
Augmedics, Ltd.
Orthopedic · 127d
Cleared Oct 03, 2025
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket...
K251468 · EZD
Hollister Incorporated
Gastroenterology & Urology · 143d
Cleared Oct 03, 2025
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
K251464 · GEX
Jeisys Medical Incorporated
General & Plastic Surgery · 143d
Cleared Oct 03, 2025
da Vinci SP Surgical System (SP1098)
K251426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 03, 2025
Bunkerhill MAC
K250662 · JAK
BunkerHill Health
Radiology · 212d
Cleared Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
K250073 · PDJ
Tosoh Bioscience, Inc.
Chemistry · 266d
Cleared Oct 03, 2025
HPACS
K250039 · LLZ
Healthhub
Radiology · 268d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031 · DQX
Abbott Medical
Cardiovascular · 269d
Cleared Oct 03, 2025
Anti Snore Mouthpiece
K250028 · LRK
Dongguan Yiyao Science & Technology...
Dental · 270d
Cleared Oct 03, 2025
Revolve Surgical System
K243968 · GCJ
Revolve Surgical, Inc.
General & Plastic Surgery · 284d
Cleared Oct 03, 2025
HESTIA (L200-A)
K242946 · GEX
Senbitec Co., Ltd.
General & Plastic Surgery · 373d
Not Cleared Oct 03, 2025
ProSense™ System
DEN220077 · QXW
Icecure Medical
General & Plastic Surgery · 1080d
Cleared Oct 02, 2025
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125,...
K252769 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · HWC
Orthonovis, Inc.
Orthopedic · 34d
Cleared Oct 02, 2025
EasyTeleMed (2.0.2)
K252440 · DRG
Ingeniars S.R.L.
Cardiovascular · 59d
Cleared Oct 02, 2025
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · JWY
Liofilchem S. R. L.
Microbiology · 87d
Cleared Oct 02, 2025
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and...
K252059 · OHA
Artivion, Inc.
Cardiovascular · 93d
Cleared Oct 02, 2025
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442 · FJK
Ningbo Tianyi Medical Appliance Co.,...
Gastroenterology & Urology · 146d
Cleared Oct 02, 2025
IPL Hair Removal Device (IPL-001, IPL-002)
K251398 · OHT
Shenzhen Enmind Technology Co., Ltd.
General & Plastic Surgery · 149d
Cleared Oct 02, 2025
Philips IntelliSpace Cardiovascular
K251215 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 167d
Cleared Oct 02, 2025
G-Bond Universal
K251124 · KLE
GC America, Inc.
Dental · 174d
Cleared Oct 02, 2025
BreatheBand® (Model 1000)
K250860 · BYI
Exemplar Medical, LLC
Anesthesiology · 195d