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
11113–11136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2023
Ag Foam Dressing Non-Adhesive (OTC)
K221754 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 215d
Cleared Jan 17, 2023
Halcyon, Ethos Radiotherapy System
K222941 · IYE
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Jan 17, 2023
Portable X-ray System
K223010 · EHD
Iray Technology Taicang , Ltd.
Radiology · 110d
Cleared Jan 17, 2023
Plasma IQ
K223222 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 92d
Cleared Jan 17, 2023
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
K223794 · OAS
Cefla S.C.
Radiology · 29d
Cleared Jan 17, 2023
FairFix QT Adjustable Button
K223795 · MBI
Medacta International S.A.
Orthopedic · 29d
Cleared Jan 17, 2023
MIM – Additional Tracers
K223800 · LLZ
Mim Software, Inc.
Radiology · 29d
Cleared Jan 13, 2023
Spectricept Skin and Wound Cleanser
K213514 · FRO
Spectrum Antimicrobials, Inc....
General & Plastic Surgery · 437d
Cleared Jan 13, 2023
Silk’n Toothwave
K214078 · QMJ
Home Skinovations , Ltd.
Dental · 382d
Cleared Jan 13, 2023
SignaSure Dual Mobility System
K220495 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 325d
Cleared Jan 13, 2023
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F,...
K221020 · EZL
Potrero Medical, Inc.
Gastroenterology & Urology · 282d
Cleared Jan 13, 2023
Scivita 4KINSIGHT ICG Imaging System
K221252 · GCJ
Scivita Medical Technology Co., Ltd.
General & Plastic Surgery · 256d
Cleared Jan 13, 2023
S-Mono
K221317 · DZE
Shinhung Mst Co., Ltd.
Dental · 252d
Cleared Jan 13, 2023
Galileo Vertebral Body Replacement Device
K221542 · PLR
Bright Spine
Orthopedic · 231d
Cleared Jan 13, 2023
Ideal Med Pro 3-Ply Disposable Face Mask
K221682 · FXX
Jsn Holdings, LLC
General Hospital · 217d
Cleared Jan 13, 2023
Antimicrobial gauze sponge dressing
K221755 · FRO
Winner Medical Co., Ltd.
General & Plastic Surgery · 211d
Cleared Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · GXP
Orthocon, Inc.
Neurology · 196d
Cleared Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
K222170 · NIE
Health Line International Corporation
Gastroenterology & Urology · 176d
Cleared Jan 13, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K222171 · OBP
Magstim Company, Ltd.
Neurology · 176d
Cleared Jan 13, 2023
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199
K222782 · HGX
Zhejiang Carebao Co., Ltd.
Obstetrics & Gynecology · 120d
Cleared Jan 13, 2023
s-Clean Link Abutment
K222913 · NHA
Dentis Co., Ltd.
Dental · 109d
Cleared Jan 13, 2023
Vibrant System
K223031 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 106d
Cleared Jan 13, 2023
Light-Guide Cables
K223183 · HBI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 93d
Cleared Jan 13, 2023
Non-Sterile Powder Free Nitrile Examination Gloves
K223221 · LZA
Dynacare Sdn Bhd
General Hospital · 88d