Search FDA 510(k) Devices

5,428 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2024–2024 ×
3,129 results
1249–1272 of 3,129
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 289d
Cleared Aug 14, 2024
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
K242077 · NFT
Aicheck Biotech, Inc.
Toxicology · 29d
Cleared Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens...
K242059 · LPL
X-Cel Specialty Contacts, A Walman...
Ophthalmic · 30d
Cleared Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED,...
K242057 · GXD
Avanos Medical, Inc.
Neurology · 30d
Cleared Aug 14, 2024
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
K241969 · NGL
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 40d
Cleared Aug 14, 2024
Intimate Rose Vaginal Dilators
K241748 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 57d
Cleared Aug 14, 2024
BostonSight® Specialty Lenses
K241571 · HQD
Boston Foundation For Sight, Inc....
Ophthalmic · 75d
Cleared Aug 14, 2024
CROSSLEAD Tracker
K241510 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 77d
Cleared Aug 14, 2024
Catapult Guide Sheath
K240957 · DYB
Contract Medical International, GmbH
Cardiovascular · 128d
Cleared Aug 14, 2024
TRAUMAGEL®
K240713 · QSY
Cresilon, Inc.
General & Plastic Surgery · 152d
Cleared Aug 14, 2024
Utepreva Endometrial Sampler (UP01)
K240595 · HFE
Utepreva, LLC
Obstetrics & Gynecology · 163d
Cleared Aug 14, 2024
Family of DIMAR DMAX NIV masks
K232836 · CBK
Dimar S.P.A.
Anesthesiology · 335d
Cleared Aug 13, 2024
Shinetell Digital Pregnancy Test
K241978 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 39d
Cleared Aug 13, 2024
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
K241813 · OUR
Si-Technology, LLC
Orthopedic · 53d
Cleared Aug 13, 2024
SUPER VELOCE
K241699 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 61d
Cleared Aug 13, 2024
Power wheelchair (N6101)
K241686 · ITI
Zhejiang Zhonglei Medical Technology...
Physical Medicine · 62d
Cleared Aug 13, 2024
Diode Laser Therapy Device (DF-DIODE LASER-S1)
K241547 · GEX
Weifang Dragonfly Electronics...
General & Plastic Surgery · 74d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 13, 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · HRS
In2bones USA
Orthopedic · 90d
Cleared Aug 13, 2024
Bullsai
K241094 · LLZ
Turing Medical Technologies, Inc.
Radiology · 113d
Cleared Aug 13, 2024
VM-2000
K240807 · CBK
Ventis Medical, Inc.
Anesthesiology · 141d
Cleared Aug 12, 2024
dS FootAnkle Coil 8ch 1.5T
K242096 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared Aug 12, 2024
OptimMRI (v2)
K242054 · QIH
Rebrain, Sas
Radiology · 28d
Cleared Aug 12, 2024
E3D™-C Interbody System
K241846 · OVE
Evolution Spine
Orthopedic · 47d