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
63217–63240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2006
NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES
K060634 · MNI
Abbott Spine, Inc.
Orthopedic · 22d
Cleared Mar 31, 2006
ONE STICK Y EXTENSION SET AND VOLUMETER
K060672 · FPA
One Stick, LLC
General Hospital · 17d
Cleared Mar 31, 2006
1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL
K060689 · MOS
Resonance Innovations, LLC
Radiology · 16d
Cleared Mar 31, 2006
SINMED POSITIONING DEVICES
K060737 · IYE
Sinmed BV
Radiology · 11d
Cleared Mar 30, 2006
P-STIM SYSTEM
K050123 · BWK
Neuroscience Therapy Corp.
Neurology · 435d
Cleared Mar 30, 2006
RF TUNNELER WIRE
K051670 · PDU
Baylis Medical Co., Inc.
Cardiovascular · 281d
Cleared Mar 30, 2006
PM-50 PULSE OXIMETER
K052693 · DQA
Shenzhen Mindray Bio-Medical...
Anesthesiology · 183d
Cleared Mar 30, 2006
NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
K053366 · LZA
Pt Mahakarya Inti Buana
General Hospital · 115d
Cleared Mar 30, 2006
SBI RADIO-CAPITELLAR IMPLANT
K060038 · JDB
Small Bone Innovations, Inc.
Orthopedic · 83d
Cleared Mar 30, 2006
FIBER-METAL POST
K060075 · ELR
Foremost Dental, LLC
Dental · 79d
Cleared Mar 30, 2006
ATRIUM FLIXENE GRAFT
K060124 · DSY
Atrium Medical Corp.
Cardiovascular · 71d
Cleared Mar 30, 2006
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS
K060303 · MBH
Biomet Manufacturing Corp
Orthopedic · 52d
Cleared Mar 29, 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS &...
K050945 · DIO
Lin-Zhi International, Inc.
Chemistry · 349d
Cleared Mar 29, 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058 · DJR
Lin-Zhi International, Inc.
Toxicology · 337d
Cleared Mar 29, 2006
ACCU-SOURCE
K051753 · JAQ
Oncology Systems, Inc.
Radiology · 273d
Cleared Mar 29, 2006
BISCO LED
K052122 · EBZ
Bisco, Inc.
Dental · 236d
Cleared Mar 29, 2006
INNOCURE IMRT FILTER (COMPENSATORS)
K052383 · IXI
Innocure, LLC
Radiology · 211d
Cleared Mar 29, 2006
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
K052525 · JIL
DFI Co., Ltd.
Chemistry · 196d
Cleared Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · LPS
Dade Behring, Inc.
Chemistry · 177d
Cleared Mar 29, 2006
PD CATH
K053123 · FJS
Med-Conduit, Inc.
Gastroenterology & Urology · 142d
Cleared Mar 29, 2006
INTERPROXIMAL REDUCTION SYSTEM
K053368 · EFB
Dentsply International
Dental · 114d
Cleared Mar 29, 2006
FIDIS CELIAC
K053383 · MST
Biomedical Diagnostics (Bmd) SA
Immunology · 114d
Cleared Mar 29, 2006
PRE-POWDERED STERILE VINYL GLOVE, CLEAR
K053521 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 100d
Cleared Mar 29, 2006
INTERX500 FLEXIBLE ARRAY ELECTRODE
K053626 · GXY
Neuro Resource Group, Inc.
Neurology · 91d