Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
40417–40440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2013
SEVIIN FRACTURE SHOULDER
K131277 · KWS
Ingen Orthopedics, LLC
Orthopedic · 114d
Cleared Aug 28, 2013
CARESCAPE MONITOR B850
K131414 · MHX
GE Healthcare Finland Oy
Cardiovascular · 104d
Cleared Aug 28, 2013
SELF-COMPRESSIVE SCREW
K131471 · HWC
Neosteo
Orthopedic · 98d
Cleared Aug 28, 2013
XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
K131507 · IYN
Toshibamedical Systems Corporation
Radiology · 96d
Cleared Aug 28, 2013
SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
K131582 · JAD
Sensus Healthcare
Radiology · 89d
Cleared Aug 28, 2013
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · FMF
Nipro Medical Corporation
General Hospital · 85d
Cleared Aug 28, 2013
LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
K132234 · LGD
DiaSorin, Inc.
Microbiology · 41d
Cleared Aug 27, 2013
NT1D VITAL SIGNS MONITOR
K123797 · DQA
New Tech, Inc.
Anesthesiology · 260d
Cleared Aug 27, 2013
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
K123987 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 244d
Cleared Aug 27, 2013
PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
K130462 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 186d
Cleared Aug 27, 2013
ZRP
K131049 · KLE
Apex Dental Materials, Inc.
Dental · 134d
Cleared Aug 27, 2013
TEETHMATE DESENSITIZER SET
K131068 · EJK
Kuraray Noritake Dental, Inc.
Dental · 132d
Cleared Aug 27, 2013
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
K131197 · NJM
Dental Morelli
Dental · 123d
Cleared Aug 27, 2013
TIPI OTC
K131198 · HHW
Contipi , Ltd.
Obstetrics & Gynecology · 123d
Cleared Aug 27, 2013
SMARTCOAT 2.5% NAF VARNISH
K131376 · LBH
Elevate Oral Care
Dental · 105d
Cleared Aug 27, 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · JOW
Covidien
Cardiovascular · 28d
Cleared Aug 26, 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436 · LCX
Church & Dwight Co., Inc.
Chemistry · 292d
Cleared Aug 26, 2013
ATG/SM-OSA APPLIANCES
K130130 · LQZ
Selane Products, Inc.
Dental · 221d
Cleared Aug 26, 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · HSD
Ingen Orthopedics, LLC
Orthopedic · 168d
Cleared Aug 26, 2013
INTERFORM INTERBODY CAGE SYSTEM
K131082 · MAX
Next Orthosurgical
Orthopedic · 130d
Cleared Aug 26, 2013
ITERO SOFTWARE
K131101 · NHA
Cadent, Ltd. an Align Technology Company
Dental · 129d
Cleared Aug 26, 2013
PREMIER CERAMIC PRIMER
K131212 · KLE
Premier Dental Products Co.
Dental · 119d
Cleared Aug 26, 2013
LOGIQ S8
K131527 · IYN
Ge Healthcare
Radiology · 90d
Cleared Aug 26, 2013
AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
K131949 · GEI
Encision, Inc.
General & Plastic Surgery · 60d