FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
28969–28992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 2017
iovera system
K161835 · GXH
Myoscience, Inc.
Neurology · 262d
Cleared Mar 24, 2017
CardioDay V2.5
K162023 · DQK
Getemed Medizin- Und...
Cardiovascular · 245d
Cleared Mar 24, 2017
PREMIUM - SHELTA Prosthetic Components
K162028 · NHA
Sweden & Martina S.P.A.
Dental · 245d
Cleared Mar 24, 2017
LUVENA VAGINAL MOISTURIZER & LUBRICANT
K162235 · NUC
Laclede, Inc.
Obstetrics & Gynecology · 227d
Cleared Mar 24, 2017
Stellaris Elite Vision Enhancement System
K162342 · HQC
Bausch & Lomb
Ophthalmic · 214d
Cleared Mar 24, 2017
Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software
K162503 · DSH
Cardiac Insight, Inc.
Cardiovascular · 198d
Cleared Mar 24, 2017
LIGHTFUSION LED SYSTEM
K162556 · GEX
Vitage Led, Ltd.
General & Plastic Surgery · 191d
Cleared Mar 24, 2017
Mould Applicator Set
K162615 · JAQ
Varian Medical Systems, Inc.
Radiology · 186d
Cleared Mar 24, 2017
VERIFY Assert Self-Contained Biological Indicator
K162701 · OWP
STERIS Corporation
General Hospital · 177d
Cleared Mar 24, 2017
GuideMia Ortho+
K162850 · PNN
Guidemia Technologies, LLC
Dental · 164d
Cleared Mar 24, 2017
nuance UNIVERSAL
K162967 · EBF
Den-Mat Holdings, LLC
Dental · 151d
Cleared Mar 24, 2017
Veloxion System
K162979 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 149d
Cleared Mar 24, 2017
GoSpiro
K163249 · BZG
Monitored Therapeutics, Inc.
Anesthesiology · 126d
Cleared Mar 24, 2017
NITRILE EXAMINATION GLOVE
K163267 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 123d
Cleared Mar 24, 2017
INFINITT ULite
K163290 · LLZ
Infinitt Co., Ltd.
Radiology · 122d
Cleared Mar 24, 2017
Scan&GO
K163297 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Mar 24, 2017
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand...
K163425 · HRS
Narang Medical USA Corporation
Orthopedic · 108d
Cleared Mar 24, 2017
NuVasive CoRoent Small Interbody System
K163491 · ODP
Nu Vasive, Incorporated
Orthopedic · 102d
Cleared Mar 24, 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587 · OWP
STERIS Corporation
General Hospital · 94d
Cleared Mar 24, 2017
FFR Link, FFR Signal Processing Module
K170204 · DRG
Boston Scientific Corporation
Cardiovascular · 60d
Cleared Mar 24, 2017
Basic, Dominant Flex
K170329 · QPB
Modela AG
General & Plastic Surgery · 50d
Cleared Mar 24, 2017
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
K170335 · HQD
Valley Contax, Inc.
Ophthalmic · 50d
Cleared Mar 24, 2017
GEN_2 and GEN_3 Mechanical Wheelchairs
K170701 · IOR
Free Wheelchair Mission
Physical Medicine · 16d
Cleared Mar 23, 2017
PerfectSmooth
K161428 · OHT
Shen Zhen Cosbeauty Co., Ltd.
General & Plastic Surgery · 304d