FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7657–7680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2024
Concentriq Dx
K230839 · PSY
Proscia, Inc.
Pathology · 318d
Cleared Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · EOQ
Fujifilm Healthcare Americas Corporation
Ear, Nose, Throat · 28d
Cleared Feb 07, 2024
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
K240064 · OAP
Wontech Co., Ltd.
General & Plastic Surgery · 29d
Cleared Feb 07, 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with...
K232764 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 152d
Cleared Feb 07, 2024
Purema® H Hemoconcentrator (EtO Sterilized)
K232171 · KDI
Tecnoideal America
Gastroenterology & Urology · 201d
Cleared Feb 07, 2024
F&P Optiflow+ Duet Nasal Cannula
K231956 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 219d
Cleared Feb 06, 2024
INNOVERSE Spinal System
K233960 · NKB
Innosys Co., Ltd.
Orthopedic · 53d
Cleared Feb 06, 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP,...
K233897 · PGY
Shenzhen Beacon Display Technology...
Radiology · 57d
Cleared Feb 06, 2024
MAGEC Spinal Bracing and Distraction System
K233593 · PGN
Nuvasive Specialized Orthopedics,...
Orthopedic · 90d
Cleared Feb 06, 2024
Cryojet Plus (SHE-ACP001-1)
K233416 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 119d
Cleared Feb 06, 2024
Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K233221 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 131d
Cleared Feb 06, 2024
Hawkeye Control Unit with Eyas Endoscope
K233115 · HRX
E Surgical, LLC
Orthopedic · 132d
Cleared Feb 06, 2024
BÜHLMANN fCAL® turbo and CALEX® Cap
K232057 · NXO
B?hlmann Laboratories AG
Immunology · 210d
Cleared Feb 05, 2024
Ziehm Vision RFD
K240099 · OWB
Ziehm Imaging GmbH
Radiology · 24d
Cleared Feb 05, 2024
Flow-Nail
K234075 · HSB
Flow-Fx, LLC
Orthopedic · 26d
Cleared Feb 05, 2024
Mg OSTEOINJECT™
K234013 · MQV
Bone Solutions, Inc.
Orthopedic · 48d
Cleared Feb 05, 2024
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A,...
K233895 · DWF
Edwards Lifesciences
Cardiovascular · 56d
Cleared Feb 05, 2024
Smart Fit Knee 3.0T
K233600 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 88d
Cleared Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · LCX
Assure Tech. (Hangzhou) Co, Ltd.
Chemistry · 130d
Cleared Feb 05, 2024
Central Monitoring System (MFM-CMS)
K232694 · MHX
Edan Instruments, Inc.
Cardiovascular · 153d
Cleared Feb 05, 2024
PREVENT Kit
K232379 · OMP
Clear Choice Therapeutics
General & Plastic Surgery · 181d
Cleared Feb 05, 2024
Viz HDS, Viz Volume Plus, Viz ICH+
K232363 · QIH
Viz. Ai, Inc.
Radiology · 182d
Cleared Feb 04, 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · GWM
Integra Lifesciences Production...
Neurology · 139d
Cleared Feb 04, 2024
X-trodes System M
K232210 · GWL
X-Trodes
Neurology · 193d