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
45409–45432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · DSY
Boston Scientific Corporation
Cardiovascular · 90d
Cleared Jan 17, 2012
AERODR SYSTEM WITH P-21
K113248 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 75d
Cleared Jan 17, 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · OVE
Medtronic Sofamor Danek
Orthopedic · 75d
Cleared Jan 17, 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · KWQ
K2m, Inc.
Orthopedic · 64d
Cleared Jan 17, 2012
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
K113366 · NKB
Phygen, LLC
Orthopedic · 63d
Cleared Jan 17, 2012
HYPERION
K113497 · MUH
Cefla S.C. Cefla Dental Group
Radiology · 53d
Cleared Jan 17, 2012
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF...
K113730 · MBI
Parcus Medical, LLC
Orthopedic · 29d
Cleared Jan 13, 2012
V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE
K110083 · CBK
Respironics California, Inc.
Anesthesiology · 367d
Cleared Jan 13, 2012
CRY-ACTRACKERCAM
K110305 · FQZ
Brymill Cryogenic Cystems
General Hospital · 345d
Cleared Jan 13, 2012
PDE PHOTODYNAMIC EYE
K110480 · OWN
Hamamatsu Photonics K.K.
General & Plastic Surgery · 329d
Cleared Jan 13, 2012
SLIM ONEBODY SYSTEM
K111162 · DZE
Dentium Co., Ltd.
Dental · 263d
Cleared Jan 13, 2012
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · LZH
Acacia, Inc.
General Hospital · 241d
Cleared Jan 13, 2012
ENDOEYE HD II
K111788 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 203d
Cleared Jan 13, 2012
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
K112013 · GEX
Biolitec, Inc.
General & Plastic Surgery · 183d
Cleared Jan 13, 2012
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
K112114 · BSZ
Maquet Critical Care AB
Anesthesiology · 172d
Cleared Jan 13, 2012
THERMO PAL INFRARED EAR THERMOMETER
K112189 · FLL
Digio2 International Co., Ltd.
General Hospital · 168d
Cleared Jan 13, 2012
VARIOUS
K112417 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 143d
Cleared Jan 13, 2012
THE VENOUS ASSIST SYSTEM
K112677 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 121d
Cleared Jan 13, 2012
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
K112707 · NJM
Ortho Technology, Inc.
Dental · 116d
Cleared Jan 13, 2012
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL...
K112727 · HWC
Medical Facets
Orthopedic · 115d
Cleared Jan 13, 2012
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
K112730 · NHA
Biomet 3i
Dental · 115d
Cleared Jan 13, 2012
BABI PLUS NEONATAL RESUSCITATION BAG
K112852 · BTM
A Plus Medical
Anesthesiology · 87d
Cleared Jan 13, 2012
ACQA
K113086 · KPS
Texas Medical Imaging Consultants
Radiology · 87d
Cleared Jan 13, 2012
VANTAGE TITAN 3T
K113093 · LNH
Toshibamedical Systems Corporation
Radiology · 86d