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
7633–7656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2024
VenaCore Thrombectomy Catheter (46-101)
K234034 · QEW
Inari Medical, Inc.
Cardiovascular · 51d
Cleared Feb 09, 2024
VERZA™ High Speed Drills
K233638 · OLO
Globus Medical, Inc.
Orthopedic · 88d
Cleared Feb 09, 2024
ZapStim Controller Application (Z1023)
K233631 · OBP
Revital Lab, Inc.
Neurology · 88d
Cleared Feb 09, 2024
WSA Self-Fitting Hearing Aid Gen 2
K233464 · QUH
Wsaud A/S
Ear, Nose, Throat · 109d
Cleared Feb 09, 2024
Infrared Thermometer: Model YJ600
K232473 · FLL
Zhuhai Yueja Medical Device...
General Hospital · 177d
Cleared Feb 09, 2024
AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G
K232072 · GEI
H.S Hospital Service S.P.A
General & Plastic Surgery · 212d
Cleared Feb 09, 2024
Neteera 130H-Plus Vital Sign Monitoring Sensor
K231733 · DRT
Neteera Technologies , Ltd.
Cardiovascular · 241d
Cleared Feb 09, 2024
Aurora
K231355 · MNR
Ensodata
Anesthesiology · 275d
Cleared Feb 08, 2024
Ion 3D
K240086 · MRW
SurGenTec, LLC
Orthopedic · 28d
Cleared Feb 08, 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069 · KNT
Endolumik
Gastroenterology & Urology · 30d
Cleared Feb 08, 2024
XVbeam2000
K233914 · EHD
Shenzhen Xpectvision Technology Co.,...
Radiology · 58d
Cleared Feb 08, 2024
Lexa MINI (RIS-303, RIS-305)
K233504 · FLE
W&H Sterilization S.R.L.
General Hospital · 100d
Cleared Feb 08, 2024
Access SHBG
K233480 · CDZ
Beckman Coulter, Inc.
Chemistry · 105d
Cleared Feb 08, 2024
Z1 Hip System
K233476 · LZO
Orchard Medical Development
Orthopedic · 106d
Cleared Feb 08, 2024
SINC Support Catheter
K233350 · DQY
Reflow Medical, Inc.
Cardiovascular · 132d
Cleared Feb 08, 2024
T2Bacteria® Panel
K233184 · QBX
T2biosystems, Inc.
Microbiology · 133d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 08, 2024
Alma Harmony
K233024 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 139d
Cleared Feb 08, 2024
Leksell GammaPlan (LGP)
K232854 · IWB
Elekta Solutions AB
Radiology · 146d
Cleared Feb 08, 2024
neuro42 MRI System
K232644 · LNH
Neuro42, Inc.
Radiology · 162d
Cleared Feb 08, 2024
T-FIT
K231913 · OAT
Techwin Co., Ltd.
Dental · 224d
Cleared Feb 08, 2024
Aid-U
K231662 · LLZ
Iaid
Radiology · 246d
Cleared Feb 08, 2024
Vecttor VT-300
K231575 · LIH
Artaflex, Inc.
Neurology · 253d
Cleared Feb 08, 2024
eQUANT System
K231536 · QZX
Avails Medical, Inc.
Microbiology · 254d