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
31465–31488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2016
Trillium Oval V 5.1 MRI System
K160152 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared May 20, 2016
MasterLoc Stem
K160289 · LZO
Medacta International
Orthopedic · 107d
Cleared May 20, 2016
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with...
K160416 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 94d
Cleared May 20, 2016
Reliance Lumbar IBF System
K160463 · MAX
Reliance Medical Systems, LLC
Orthopedic · 91d
Cleared May 20, 2016
Planmeca ProMax 3D Max, Planmeca Maximity
K160506 · OAS
Planmeca Oy
Radiology · 86d
Cleared May 20, 2016
ViZion DR + Wireless
K160810 · MQB
Viztek, LLC
Radiology · 57d
Cleared May 20, 2016
United Urologics Closed System Catheter
K160877 · KOD
Robling Medical, Inc.
Gastroenterology & Urology · 51d
Cleared May 20, 2016
BIB Stent Placement Catheter
K160889 · NVM
NuMED, Inc.
Cardiovascular · 50d
Cleared May 20, 2016
Baha 5 Power Sound Processor
K161123 · LXB
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
K161140 · JIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared May 19, 2016
Filbloc
K150553 · NEW
Assut Europe
General & Plastic Surgery · 442d
Cleared May 19, 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452 · LEJ
Medtek Lighting Corp D/B/A Peacock...
General & Plastic Surgery · 265d
Cleared May 19, 2016
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
K152466 · EOQ
Prosurg, Inc.
Ear, Nose, Throat · 262d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS...
K152842 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 233d
Cleared May 19, 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice...
K153107 · MAX
Choicespine, LP
Orthopedic · 205d
Cleared May 19, 2016
EasyPass Guidewire
K153264 · OCY
Medi-Globe Corporation
Gastroenterology & Urology · 189d
Cleared May 19, 2016
Target Detachable Coils
K153658 · HCG
Stryker Neurovascular
Neurology · 150d
Cleared May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778 · KRD
Cook Incorporated
Cardiovascular · 140d
Cleared May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
K160290 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 19, 2016
EMPOWR PS Knee System
K160342 · JWH
Encore Medical, L.P.
Orthopedic · 101d
Cleared May 19, 2016
SmartStart Air/Water and Suction Valves
K160403 · ODC
Endochoice, Inc.
Gastroenterology & Urology · 97d
Cleared May 19, 2016
Navio
K160537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared May 19, 2016
C2 CryoBalloon Focal Pear Catheter
K160994 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 41d
Cleared May 19, 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · HRS
Osteomed
Orthopedic · 36d