Search FDA 510(k) Devices

5,441 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1489–1512 of 174,061
Cleared Oct 06, 2025
Wheelchair (N817)
K251565 · ITI
Zhejiang Topwe Tools Manufacturing...
Physical Medicine · 137d
Cleared Oct 06, 2025
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal...
K250173 · BTR
Covidien, LLC
Anesthesiology · 258d
Cleared Oct 03, 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
K252820 · GAM
Internacional Farmac?utica S.A DE C.V
General & Plastic Surgery · 29d
Cleared Oct 03, 2025
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU,...
K252806 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 30d
Cleared Oct 03, 2025
Manual Wheelchair (SYIV100A008)
K252517 · IOR
Ningbo Shenyu Medical Equipment Co.,Ltd
Physical Medicine · 53d
Cleared Oct 03, 2025
MAGENTIQ-COLO (ME-APDS)
K252178 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 84d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC
Smith & Nephew, Inc.
Orthopedic · 88d
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
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