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
7321–7344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2024
Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central...
K234130 · MWI
Ge Medical Systems Information...
Anesthesiology · 83d
Cleared Mar 20, 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090 · IZI
Surgvision GmbH
General & Plastic Surgery · 89d
Cleared Mar 20, 2024
Access Ferritin
K234052 · JMG
Beckman Coulter, Inc.
Immunology · 90d
Cleared Mar 20, 2024
Straumann® BLC and TLC Implants - Line extension
K234049 · DZE
Institut Straumann AG
Dental · 90d
Cleared Mar 20, 2024
Automatic Registration
K234047 · OLO
Brainlab AG
Orthopedic · 90d
Cleared Mar 20, 2024
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008,...
K233901 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 100d
Cleared Mar 20, 2024
InMode RF System
K233642 · GEI
Inmode , Ltd.
General & Plastic Surgery · 128d
Cleared Mar 20, 2024
Tranquil-L Interbody System
K233375 · MAX
Nexus Spine, LLC
Orthopedic · 170d
Cleared Mar 20, 2024
BEED 2,5, BEED 3,8
K233002 · GEI
Excelsior Resources, LLC
General & Plastic Surgery · 180d
Cleared Mar 20, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For...
K232654 · LZA
Nephron Nitrile, LLC
General Hospital · 202d
Cleared Mar 20, 2024
V-PVP
K232125 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 247d
Cleared Mar 20, 2024
PATHFAST®hs-cTnI-II
K231974 · MMI
Phc Corporation
Chemistry · 261d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668 · GXY
Shenzhen Amydi-Med Electrics Tech...
Neurology · 11d
Cleared Mar 19, 2024
HWJECT Auto-disable syringe
K234024 · FMF
Anhui Hongyu Wuzhou Medical...
General Hospital · 90d
Cleared Mar 19, 2024
Disposable Dual Action Tissue Closure Device
K233772 · PKL
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 116d
Cleared Mar 19, 2024
Blood Pressure Monitor
K233146 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 174d
Cleared Mar 19, 2024
Pre-Sintered Zirconia Coloring Liquid
K232682 · EIH
Chengdu Besmile Medical Technology...
Dental · 200d
Cleared Mar 19, 2024
MATRIX HA PEEK Cervical IBF System
K232619 · ODP
Sapphire Medical Group
Orthopedic · 203d
Cleared Mar 19, 2024
ARX Viral Transport Media Collection and Transport System
K231843 · JSM
Arx Sciences, Inc.
Microbiology · 271d
Cleared Mar 19, 2024
Medical Surgical Mask
K231719 · FXX
Azur Medical Company, Inc.
General Hospital · 280d
Cleared Mar 18, 2024
uNion® MAX Cervical Plate System
K240515 · KWQ
Ulrich Medical USA, Inc.
Orthopedic · 24d
Cleared Mar 18, 2024
Real Intelligence™ CORI™
K240139 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 60d
Cleared Mar 18, 2024
CORIOGRAPH Knee Pre-Op Plan
K240113 · PBF
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Mar 18, 2024
nCommand Lite System
K233660 · LLZ
Ionic Health
Radiology · 124d