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
8545–8568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2023
Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801,...
K230500 · IRP
Jiangsu Maxf Electric Appliance Co.,...
Physical Medicine · 244d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 262d
Cleared Oct 26, 2023
Antimicrobial Gelling Fiber Dressing with PHMB
K213473 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 728d
Cleared Oct 25, 2023
sam CS Long Duration Ultrasound Device
K233210 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 27d
Cleared Oct 25, 2023
PiXel8-RF
K233147 · GEI
Rohrer Aesthetics
General & Plastic Surgery · 28d
Cleared Oct 25, 2023
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L,...
K233113 · KNS
Starmed Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Oct 25, 2023
Balanced Knee® System TriMax PS Plus Tibial Insert
K233093 · JWH
Ortho Development Corporation
Orthopedic · 29d
Cleared Oct 25, 2023
Rapid SDH
K232436 · QAS
Ischemaview, Inc.
Radiology · 72d
Cleared Oct 25, 2023
Magstim®Horizon® 3.0 TMS Therapy System
K232235 · OBP
The Magstim Company , Ltd.
Neurology · 90d
Cleared Oct 25, 2023
AcuityUDR
K231995 · KPR
Radmedix, LLC
Radiology · 112d
Cleared Oct 25, 2023
POWERSEAL Sealer and Divider
K231327 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 170d
Cleared Oct 25, 2023
PERLA® TL Posterior Thoraco-lumbar Fixation System
K231069 · NKB
Spineart SA
Orthopedic · 194d
Cleared Oct 25, 2023
SignalHF (IM008)
K230842 · QNL
Implicity, Inc.
Cardiovascular · 211d
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · KKX
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared Oct 25, 2023
K3900 Ultrasound Imaging System
K230511 · IYO
Maui Imaging
Radiology · 243d
Cleared Oct 25, 2023
Penumbra LP Coil System
K230284 · HCG
Penumbra, Inc.
Neurology · 265d
Cleared Oct 25, 2023
VVR Generator system
K222997 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 392d
Cleared Oct 25, 2023
Newclip Patient-matched instrumentation non sterile PSI
K221615 · PBF
Newclip Technics
Orthopedic · 509d
Cleared Oct 25, 2023
UNIdental Symphony Implant System
K221315 · DZE
Unidental Co., Ltd.
Dental · 537d
Cleared Oct 24, 2023
16 Breast Coil
K233348 · MOS
Philips Medical System Nederlands B.V.
Radiology · 25d
Cleared Oct 24, 2023
MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System
K233185 · GEI
C2dx, Inc.
General & Plastic Surgery · 26d
Cleared Oct 24, 2023
Knotilus+ PEEK Knotless Anchor
K232683 · MBI
Stryker Endoscopy
Orthopedic · 53d
Cleared Oct 24, 2023
FilteredFlo Warming Blankets
K232638 · DWJ
Iob Medical, Inc.
Cardiovascular · 55d
Cleared Oct 24, 2023
Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
K232586 · NKB
K&J Consulting Corp.
Orthopedic · 60d