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
20689–20712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2019
Pantheon Spinal Pontus Interbody Fusion Device
K181548 · MAX
Pantheon Spinal
Orthopedic · 552d
Cleared Dec 16, 2019
SunClear Aligner system
K190394 · NXC
Sun Dental Laboratories, LLC
Dental · 300d
Cleared Dec 16, 2019
Lawson Retrograde Nephrostomy Wire Puncture Set
K190903 · LJE
Cook Incorporated
Gastroenterology & Urology · 252d
Cleared Dec 16, 2019
Llis, Vittra APS
K191306 · EBF
Dentscare Ltda
Dental · 216d
Cleared Dec 16, 2019
EM Provisional
K191751 · DZE
Hiossen, Inc.
Dental · 168d
Cleared Dec 16, 2019
Stand-Alone ALIF Titanium System
K191834 · OVD
Life Spine, Inc.
Orthopedic · 160d
Cleared Dec 16, 2019
Deka Luxea
K192539 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 91d
Cleared Dec 16, 2019
CORRIDOR Fixation System
K192744 · MRW
Globus Medical, Inc.
Orthopedic · 77d
Cleared Dec 16, 2019
Physio Flex Annuloplasty Ring
K192762 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 77d
Cleared Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
K192943 · DJG
Microgenics Corporation
Toxicology · 59d
Cleared Dec 16, 2019
Keos Lumbar IBFD
K193174 · MAX
Keos
Orthopedic · 28d
Cleared Dec 15, 2019
AXS Vecta Aspiration Catheter
K190833 · DQY
Stryker Neurovascular
Neurology · 258d
Cleared Dec 14, 2019
Airlock Centrolock Osteosynthesis Implant System
K192356 · HRS
Novastep
Orthopedic · 107d
Cleared Dec 13, 2019
Corelink Navigation Instruments
K182731 · OLO
Corelink, LLC
Orthopedic · 441d
Cleared Dec 13, 2019
Ambar, Ambar APS, Ambar Universal APS
K183424 · KLE
Dentscare Ltda
Dental · 367d
Cleared Dec 13, 2019
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor...
K190715 · ERL
Interscope, Inc.
Ear, Nose, Throat · 269d
Cleared Dec 13, 2019
Infrared Thermometer, model: PC808
K190717 · FLL
Shenzhen Pacom Medical Instruments...
General Hospital · 268d
Cleared Dec 13, 2019
MyShoulder Placement Guides
K190738 · PHX
Medacta International S.A.
Orthopedic · 266d
Cleared Dec 13, 2019
EPIFLO-28
K190742 · KPJ
Neogenix, LLC Dba Ogenix
General & Plastic Surgery · 266d
Cleared Dec 13, 2019
Satisfaite
K190752 · NUC
Femmepharma Consumer Healthcare, LLC
Obstetrics & Gynecology · 263d
Cleared Dec 13, 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 232d
Cleared Dec 13, 2019
Avanti Distal Radius and Forearm System
K191118 · HRS
Avanti Orthopaedics, Inc.
Orthopedic · 231d
Cleared Dec 13, 2019
Neo Cage System
K191796 · MAX
Neo Medical SA
Orthopedic · 163d
Cleared Dec 13, 2019
Icobrain
K192130 · LLZ
Icometrix NV
Radiology · 128d