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

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175,820 results
41665–41688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2013
BOEHRINGER GASTRIC SIZING TUBE
K130483 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 31d
Cleared Mar 28, 2013
12MM AND 13MM TIBIAL NAILS
K130625 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 20d
Cleared Mar 27, 2013
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
K113823 · CFN
The Binding Site Group , Ltd.
Immunology · 456d
Cleared Mar 27, 2013
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER,...
K121823 · JFS
Wescor, Inc.
Chemistry · 279d
Cleared Mar 27, 2013
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
K122480 · BYI
International Biophysics Corporation
Anesthesiology · 225d
Cleared Mar 27, 2013
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
K122494 · LYA
Hemostasis, LLC
Ear, Nose, Throat · 223d
Cleared Mar 27, 2013
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
K123762 · DWF
Medtronic, Inc.
Cardiovascular · 110d
Cleared Mar 27, 2013
TBD
K123859 · OOE
Lensar, Inc.
Ophthalmic · 103d
Cleared Mar 27, 2013
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
K123870 · DZE
Megagen Implant Co., Ltd.
Dental · 100d
Cleared Mar 27, 2013
MICROLINE FLEXIBLE LIGATING SHEARS
K124029 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 26, 2013
SMART-WELL INCUBATOR
K122362 · FRC
Mesa Laboratories, Inc.
General Hospital · 232d
Cleared Mar 26, 2013
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
K122560 · CBK
Pan-America Hyperbarics, Inc.
Anesthesiology · 216d
Cleared Mar 26, 2013
INSIGNIA DIGICAST
K123118 · DYW
Ormco Corp.
Dental · 174d
Cleared Mar 26, 2013
ULTRASAFE PLUS PASSIVE NEEDLE GUARD
K123743 · MEG
Safety Syringes, Inc.
General Hospital · 110d
Cleared Mar 26, 2013
NOBELCLINICIAN
K123976 · LLZ
Nobel Biocare AB
Radiology · 90d
Cleared Mar 26, 2013
HIGH METABOLITE QUALICHECK
K130415 · JJS
Radiometer Medical Aps
Chemistry · 35d
Cleared Mar 26, 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT
K130671 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 14d
Cleared Mar 25, 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 451d
Cleared Mar 25, 2013
LIFELINES IEEG
K123665 · OLT
Kvikna Ehf
Neurology · 117d
Cleared Mar 25, 2013
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
K123745 · HSB
Biomecanica Industria E Comerico DE...
Orthopedic · 109d
Cleared Mar 25, 2013
AQUABOSS ECORO DIA I (HT)
K124059 · FIP
Lauer Membran Wassertechnik GmbH
Gastroenterology & Urology · 84d
Cleared Mar 25, 2013
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K130173 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 60d
Cleared Mar 25, 2013
RAMPART O AND RAMPART P
K130396 · MAX
Spineology, Inc.
Orthopedic · 34d
Cleared Mar 25, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K130754 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 6d