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
24721–24744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2018
Youlaser CO2
K182669 · GEX
Quanta System Spa
General & Plastic Surgery · 22d
Cleared Oct 16, 2018
KidCap
K180568 · MVA
Eastern Cranial Affiliates, LLC
Neurology · 225d
Cleared Oct 16, 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · NXO
Inova Diagnostics, Inc.
Immunology · 186d
Cleared Oct 16, 2018
Pump In Style Advanced, Advanced Personal Double Breastpump
K181937 · HGX
Medela, LLC
Obstetrics & Gynecology · 89d
Cleared Oct 16, 2018
Depuy Synthes Femoral Neck System
K182154 · KTT
Synthes USA Products, LLC
Orthopedic · 68d
Cleared Oct 16, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
K182261 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 56d
Cleared Oct 16, 2018
RCT700
K182614 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Oct 15, 2018
Reliant(TM) Multistage Dilatation Balloon Catheter
K180418 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 242d
Cleared Oct 15, 2018
DynaBridge
K181815 · JDR
Fusion Orthopedics, LLC
Orthopedic · 98d
Cleared Oct 15, 2018
BracePaste MTP Light Cure Primer
K181910 · KLE
American Orthodontics
Dental · 90d
Cleared Oct 15, 2018
NeuroBlate System
K182036 · GEX
Monteris Medical,
Neurology · 77d
Cleared Oct 15, 2018
FlowTriever Retrieval/Aspiration System
K182233 · QEW
Inari Medical
Cardiovascular · 59d
Cleared Oct 12, 2018
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · DCN
The Binding Site Group , Ltd.
Chemistry · 269d
Cleared Oct 12, 2018
PENTAX Video Upper G.I. Scope EG34-i10
K180292 · FDS
Pentax Medical of America, Inc.
Gastroenterology & Urology · 253d
Cleared Oct 12, 2018
b-ONE Total Knee System
K180446 · JWH
B-One Ortho, Corp.
Orthopedic · 234d
Cleared Oct 12, 2018
Endophys Pressure Sensing Sheath Kit
K180620 · DYB
Endophys Holdings, LLC
Cardiovascular · 217d
Cleared Oct 12, 2018
AG 100s
K180991 · BSK
Hospitech Respiration , Ltd.
Anesthesiology · 179d
Cleared Oct 12, 2018
Juell 3D Volo Base
K181220 · EBI
Park Dental Research Corporation
Dental · 158d
Cleared Oct 12, 2018
OSSDSIGN Cranioplug
K181539 · GXR
Ossdsign AB
Neurology · 123d
Cleared Oct 12, 2018
BKS Revision Sleeves System
K181569 · JWH
Ortho Development Corporation
Orthopedic · 120d
Cleared Oct 12, 2018
Thorecon Rigid Fixation System
K181607 · JDQ
A & E Medical Corporation
Orthopedic · 115d
Cleared Oct 12, 2018
X-BOLT Hip Fracture Fixation System
K181640 · HSB
X-Bolt Orthopaedics
Orthopedic · 113d
Cleared Oct 12, 2018
EIT Cellular Titanium® Lumbar Cage LLIF
K181644 · MAX
Eit Emerging Implant Technologies GmbH
Orthopedic · 112d
Cleared Oct 12, 2018
Radial Medical Compression System
K181651 · JOW
Radial Medical, Inc.
Cardiovascular · 112d