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
39817–39840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2013
ILLUMASK ACNE LIGHT THERAPY MASK
K123999 · OLP
La Lumiere, LLC
General & Plastic Surgery · 245d
Cleared Aug 28, 2013
STALIF X
K130461 · OVD
Centinel Spine, Inc.
Orthopedic · 187d
Cleared Aug 28, 2013
BIORETEC ACTIVASCREW INTERFERENCE
K130716 · MAI
Bioretec, Ltd.
Orthopedic · 166d
Cleared Aug 28, 2013
LIDCO CNAP MODULE
K131048 · DXG
Lidco, Ltd.
Cardiovascular · 135d
Cleared Aug 28, 2013
RESTORE BUNION CORRECTION SYSTEM
K131061 · JDR
Nextremity Solutions
Orthopedic · 134d
Cleared Aug 28, 2013
COLIGN
K131124 · DTL
Jilin Coronado Medical , Ltd.
Cardiovascular · 128d
Cleared Aug 28, 2013
UGFT3
K131155 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Aug 28, 2013
SONICISION STERILIZATION TRAY
K131170 · KCT
Covidien, Formerly Valleylab, A...
General Hospital · 126d
Cleared Aug 28, 2013
LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
K131221 · NQK
Biomonde
General & Plastic Surgery · 120d
Cleared Aug 28, 2013
CARESCAPE MONITOR B650
K131223 · MHX
GE Healthcare Finland Oy
Cardiovascular · 120d
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