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
76657–76680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2001
ETHANOL
K013538 · DML
Abbott Laboratories
Toxicology · 51d
Cleared Dec 14, 2001
SHOULDER COIL
K013541 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 14, 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K013703 · MQG
Sanyo North America Corp.
Obstetrics & Gynecology · 36d
Cleared Dec 14, 2001
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · GXY
Apex Medical Corp.
Neurology · 28d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866 · DBY
Boston Scientific
Immunology · 23d
Cleared Dec 14, 2001
JOSTRA FLOWPROBE FP-32E
K013939 · DPT
Jostra AG
Cardiovascular · 15d
Cleared Dec 13, 2001
STRESS GUARD, MODEL HERDEV1
K004008 · GZJ
Herbo Medex International, Inc.
Neurology · 352d
Cleared Dec 13, 2001
MODIFICATION TO THE GRIP
K010526 · LIX
Elcare Innovations, Inc.
Cardiovascular · 294d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · HRX
Clarus Medical, LLC
Orthopedic · 216d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · KWS
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Dec 13, 2001
CAIRD TECHNOLOGY HOLTER 2000
K012686 · DPS
Caird Technology
Cardiovascular · 121d
Cleared Dec 13, 2001
WET LIGHT PERSONAL MOISTURIZER
K013086 · HIS
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 13, 2001
SOPRO 67D OPERATING ROOM CAMERA
K013090 · GCJ
Sopro
General & Plastic Surgery · 87d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · FTD
STERIS Corporation
General & Plastic Surgery · 76d
Cleared Dec 13, 2001
DXS DIGITAL X-RAY SYSTEM
K013271 · MUH
Douglas C. Yoon, Dds
Radiology · 73d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Dec 13, 2001
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K013337 · HNO
Surgin, Inc.
Ophthalmic · 65d
Cleared Dec 13, 2001
DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
K013358 · DXN
Pulse Metric, Inc.
Cardiovascular · 64d
Cleared Dec 13, 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · DPS
Reynolds Medical , Ltd.
Cardiovascular · 64d
Cleared Dec 13, 2001
INDIGO OPTIMA LASER SYSTEM
K013493 · GEX
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 52d
Cleared Dec 13, 2001
INVACARE ELEVATING SEAT OPTION ESS6
K013516 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Dec 13, 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · MOS
Usa Instruments, Inc.
Radiology · 51d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · LXT
Ebi, L.P.
Orthopedic · 30d