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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
59977–60000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2007
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
K063674 · LZG
Animas Corp.
General Hospital · 109d
Cleared Mar 30, 2007
ALPHA BIO BONE FIXATION SCREW SYSTEM
K063769 · DZL
Alpha-Bio Tec , Ltd.
Dental · 100d
Cleared Mar 30, 2007
TOKUYAMA BOND FORCE
K070215 · KLE
Tokuyama Dental Corporation
Dental · 66d
Cleared Mar 30, 2007
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
K070729 · GWN
Fall Prevention Technologies, LLC
Neurology · 15d
Cleared Mar 29, 2007
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
K063076 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 174d
Cleared Mar 29, 2007
MA 55 MAESTRO
K063452 · EWO
Maico Diagnostics (Diagnostic Group,...
Ear, Nose, Throat · 134d
Cleared Mar 29, 2007
DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEM
K063874 · DZE
Blue Sky Bio, LLC
Dental · 90d
Cleared Mar 29, 2007
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02
K070127 · EMN
Kevin Vu, Dds
Dental · 72d
Cleared Mar 29, 2007
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
K070177 · KPO
Fresenius Medical Care North America
Gastroenterology & Urology · 70d
Cleared Mar 29, 2007
R&D SICKLE QC CONTROL
K070334 · GGM
R&D Systems, Inc.
Hematology · 52d
Cleared Mar 29, 2007
ARGON CONTINUOUS FLUSH DEVICE
K070384 · KRA
Argon Medical Devices, Inc.
Cardiovascular · 48d
Cleared Mar 29, 2007
MODIFICATION TO POLAR CARE 500
K070402 · ILO
Breg, Inc.
Physical Medicine · 45d
Cleared Mar 29, 2007
NEWDEAL COMPRESSION PLATE
K070447 · HRS
Newdeal Sas
Orthopedic · 42d
Cleared Mar 29, 2007
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
K070507 · HWC
Science For Biomaterials
Orthopedic · 36d
Cleared Mar 29, 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 34d
Cleared Mar 29, 2007
C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
K070548 · FZP
Cardica, Inc.
General & Plastic Surgery · 31d
Cleared Mar 29, 2007
MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K070551 · NKB
Pioneer Surgical Technology
Orthopedic · 30d
Cleared Mar 29, 2007
HEMOSIL PROCLOT
K070635 · GGP
Instrumentation Laboratory CO
Hematology · 22d
Cleared Mar 29, 2007
COE SOFT
K070697 · EBI
GC America, Inc.
Dental · 16d
Cleared Mar 29, 2007
COE COMFORT
K070698 · EBI
GC America, Inc.
Dental · 16d
Cleared Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
K061377 · MSJ
Pointe Scientific, Inc.,
Chemistry · 315d
Cleared Mar 28, 2007
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
K070041 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 84d
Cleared Mar 28, 2007
MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
K070052 · KWD
Vilex, Inc.
Orthopedic · 83d
Cleared Mar 28, 2007
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208 · HRS
Synthes (Usa)
Orthopedic · 65d