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
9649–9672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2023
ClearTip
K231267 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 59d
Cleared Jun 30, 2023
Easy On Universal Glaze & Stain
K231264 · EIH
Doctus Global
Dental · 59d
Cleared Jun 30, 2023
Ventana™ L Spinal System
K231252 · MAX
Spinal Elements, Inc.
Orthopedic · 60d
Cleared Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 85d
Cleared Jun 30, 2023
MeMed BV
K230944 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 87d
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or...
K230935 · JWY
Thermo Fisher Scientific
Microbiology · 88d
Cleared Jun 30, 2023
REMI Remote EEG Monitoring System
K230933 · OMC
Epitel, Inc.
Neurology · 88d
Cleared Jun 30, 2023
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · FEB
STERIS Corporation
General Hospital · 88d
Cleared Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
K230917 · QXA
Lumos Diagnostics, Inc.
Microbiology · 88d
Cleared Jun 30, 2023
Compact Wearable Pump
K230469 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 129d
Cleared Jun 30, 2023
SGM Femoral Nail System
K230456 · HSB
Changzhou Geasure Medical Apparatus...
Orthopedic · 129d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide...
K230156 · DQY
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 30, 2023
Inogen Rove 6
K230052 · CAW
Inogen, Inc.
Anesthesiology · 175d
Cleared Jun 30, 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · JKA
Owen Mumford, Ltd.
General Hospital · 189d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694 · KLW
Duearity AB
Ear, Nose, Throat · 203d
Cleared Jun 30, 2023
Blood Pressure Monitor
K223374 · DXN
Guangdong Transtek Medical...
Cardiovascular · 238d
Cleared Jun 30, 2023
AblatePal Radiofrequency Ablation System
K223135 · GEI
Compal Electronics, Inc.
General & Plastic Surgery · 270d
Cleared Jun 30, 2023
AirTom
K222466 · QEB
Bilab
Anesthesiology · 318d
Cleared Jun 30, 2023
preCARDIA Occlusion System
K221294 · MJN
Abiomed, Inc.
Cardiovascular · 422d
Cleared Jun 30, 2023
Pixyl.Neuro
K213253 · LLZ
Pixyl SA
Radiology · 638d
Cleared Jun 30, 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · MRN
Airgas Therapeutics
Anesthesiology · 696d
Cleared Jun 29, 2023
Phantom XL Insulated Dilators
K231691 · GXZ
TeDan Surgical Innovations, Inc.
Neurology · 20d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647 · MOS
Polarean, Inc.
Radiology · 24d
Cleared Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
K231553 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 30d