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
65545–65568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2005
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · FDF
Olympus America, Inc.
Radiology · 21d
Cleared Jun 30, 2005
PENTATRASFU BLOOD TRANSFUSION SETS
K041496 · BRZ
Pentaferte S.P.A
General Hospital · 391d
Cleared Jun 30, 2005
MC+ PARTIAL VBR
K043479 · MQP
Ldr Spine USA
Orthopedic · 196d
Cleared Jun 30, 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · JFM
Stanbio Laboratory
Chemistry · 146d
Cleared Jun 30, 2005
CREATININE LIQUICOLOR
K050283 · JFY
Stanbio Laboratory
Chemistry · 143d
Cleared Jun 30, 2005
PEDIATRIC CUFFED AND UNCUFFED ET TUBES
K050803 · BTR
Vitaid, Ltd.
Anesthesiology · 92d
Cleared Jun 30, 2005
WAVELIGHT AURIGA
K051399 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 30d
Cleared Jun 30, 2005
6 FR FL POWERHOHN AND POWERLINE CATHETER
K051417 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jun 30, 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491 · LPH
Zimmer, Inc.
Orthopedic · 24d
Cleared Jun 30, 2005
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
K051557 · JDS
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Jun 29, 2005
DATEX-OHMEDA OXY-AFR SENSOR
K042891 · NLF
Datex-Ohmeda
Anesthesiology · 253d
Cleared Jun 29, 2005
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
K043349 · MQP
Ldr Spine USA
Orthopedic · 205d
Cleared Jun 29, 2005
TAPER 2 POROUS FEMORAL STEM
K050441 · JDI
Biomet, Inc.
Orthopedic · 127d
Cleared Jun 29, 2005
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799 · GGN
Biosite Incorporated
Hematology · 91d
Cleared Jun 29, 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC...
K050802 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 91d
Cleared Jun 29, 2005
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · GAM
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Jun 29, 2005
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
K050858 · DPS
Heartlab, Inc.
Cardiovascular · 85d
Cleared Jun 29, 2005
DADE THROMBIN REAGENT
K050928 · KQJ
Dade Behring, Inc.
Hematology · 76d
Cleared Jun 29, 2005
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
K050953 · CAH
Air Safety, Ltd.
General Hospital · 75d
Cleared Jun 29, 2005
R-X-FIX EXTERNAL FIXATOR
K051017 · KTT
R-X-Fix
Orthopedic · 69d
Cleared Jun 29, 2005
STALIF TT
K051027 · MQP
Surgicraft , Ltd.
Orthopedic · 68d
Cleared Jun 29, 2005
SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G,...
K051050 · KLE
Schutz-Dental GmbH
Dental · 65d
Cleared Jun 29, 2005
VISULIZE FACTOR IX ANTIGEN KIT
K051054 · GGP
Affinity Biologicals, Inc.
Hematology · 64d
Cleared Jun 29, 2005
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
K051069 · MBI
Arthrotek, Inc.
Orthopedic · 64d