FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
21289–21312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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 CT 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
Cleared Dec 13, 2019
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ...
K192152 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 126d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Cleared Dec 13, 2019
Aero Blue Performance Surgical Gowns
K192362 · FYA
O&M Halyard, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · DXT
Bayer Medical Care, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
QyScore Software
K192531 · LLZ
Qynapse
Radiology · 88d
Cleared Dec 13, 2019
decimal3D
K192554 · MUJ
.Decimal, LLC
Radiology · 87d
Cleared Dec 13, 2019
Diode Laser Therapy System
K192569 · GEX
San HE Lefis Electronics Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 13, 2019
Laser Hair Growth Cap
K192627 · OAP
Shang FA Biotechnology Co.
General & Plastic Surgery · 81d
Cleared Dec 13, 2019
neria guard Infusion Set
K192647 · FPA
Unomedical A/S
General Hospital · 80d
Cleared Dec 13, 2019
Demetra BDEM-01 Dermatoscope
K192829 · PSN
Barco N.V.
General & Plastic Surgery · 72d