FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7921–7944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2024
Z1 Hip System
K233476 · LZO
Orchard Medical Development
Orthopedic · 106d
Cleared Feb 08, 2024
SINC Support Catheter
K233350 · DQY
Reflow Medical, Inc.
Cardiovascular · 132d
Cleared Feb 08, 2024
T2Bacteria® Panel
K233184 · QBX
T2biosystems, Inc.
Microbiology · 133d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 08, 2024
Alma Harmony
K233024 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 139d
Cleared Feb 08, 2024
Leksell GammaPlan (LGP)
K232854 · IWB
Elekta Solutions AB
Radiology · 146d
Cleared Feb 08, 2024
neuro42 MRI System
K232644 · LNH
Neuro42, Inc.
Radiology · 162d
Cleared Feb 08, 2024
T-FIT
K231913 · OAT
Techwin Co., Ltd.
Dental · 224d
Cleared Feb 08, 2024
Aid-U
K231662 · LLZ
Iaid
Radiology · 246d
Cleared Feb 08, 2024
Vecttor VT-300
K231575 · LIH
Artaflex, Inc.
Neurology · 253d
Cleared Feb 08, 2024
eQUANT System
K231536 · QZX
Avails Medical, Inc.
Microbiology · 254d
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