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
47041–47064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2011
STERI-DENT, STERI-SURE
K094026 · KMH
Cpac, Inc.
General Hospital · 559d
Cleared Jul 12, 2011
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K101997 · HSB
Ellipse Technologies, Inc.
Orthopedic · 362d
Cleared Jul 12, 2011
PRO FIXATION SYSTEM
K110538 · HWC
Synovis Orthopedic & Woundcare
Orthopedic · 137d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE...
K110670 · HRS
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Jul 12, 2011
EASYFIT SILKGEL NASAL MASK
K110884 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 104d
Cleared Jul 12, 2011
EASYRA HDL REAGENT
K111036 · LBS
Medica Corporation
Chemistry · 89d
Cleared Jul 12, 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076 · NKB
Alphatec Spine, Inc.
Orthopedic · 85d
Cleared Jul 12, 2011
ORTHOSORB RESORBABLE PINS
K111077 · OVZ
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · MBI
Arthrocare Corp.
Orthopedic · 54d
Cleared Jul 12, 2011
ENDOLOGIX AFX INTRODUCER SYSTEM
K111747 · DYB
Endologix, Inc.
Cardiovascular · 20d
Cleared Jul 11, 2011
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
K101194 · FRN
Carticept Medical, Inc.
General Hospital · 439d
Cleared Jul 11, 2011
ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENT
K110824 · GEI
Aragon Surgical, Inc.
General & Plastic Surgery · 110d
Cleared Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · GJT
Instrumentation Laboratory CO
Hematology · 163d
Cleared Jul 08, 2011
PAINFUSOR CATHETER
K111031 · BSO
Plan 1 Health, S.R.L.
Anesthesiology · 85d
Cleared Jul 08, 2011
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K111150 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 74d
Cleared Jul 08, 2011
DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K111435 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 46d
Cleared Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
K111506 · JJY
Roche Diagnostics
Chemistry · 37d
Cleared Jul 08, 2011
RHA2020
K111531 · HLI
Annidis Health Systems Corp.
Ophthalmic · 36d
Cleared Jul 08, 2011
HERO
K111601 · DPS
Medical Predictive Science Corp.
Cardiovascular · 30d
Cleared Jul 08, 2011
MEDIOSTAR NEXT
K111851 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 9d
Cleared Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · JXG
Integra LifeSciences Corporation
Neurology · 416d
Cleared Jul 07, 2011
SURELIFT PROLAPSE SYSTEM
K102815 · OTP
Neomedic International
Obstetrics & Gynecology · 282d
Cleared Jul 07, 2011
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH...
K103714 · KGO
Ansell Healthcare Products, LLC
General Hospital · 198d
Cleared Jul 07, 2011
FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
K110044 · DXN
Foracare, Inc.
Cardiovascular · 182d