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
32329–32352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2016
Diplomat® Spinal System
K151704 · NKB
Signus Medizintechnik GmbH
Orthopedic · 294d
Cleared Apr 13, 2016
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
K151953 · DXN
A&D Company, Ltd.
Cardiovascular · 273d
Cleared Apr 13, 2016
Coldplay Cryoballoon
K152329 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 239d
Cleared Apr 13, 2016
JRP Wound Spreader
K152538 · GAD
J.R. Parker, LLC
General & Plastic Surgery · 222d
Cleared Apr 13, 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30...
K153038 · MAV
Medtronic, Inc.
Cardiovascular · 177d
Cleared Apr 13, 2016
Juno VPAP ST-A
K153061 · MNS
Resmed, Ltd.
Anesthesiology · 175d
Cleared Apr 13, 2016
Ketac Universal Aplicap
K153174 · EMA
3M Deutschland GmbH
Dental · 162d
Cleared Apr 13, 2016
Aero Chrome* Breathable Performance Surgical Gown
K153255 · FYA
Halyard Health, Inc.
General Hospital · 155d
Cleared Apr 13, 2016
NuVasive CoRoent Thoracolumbar System
K153419 · MAX
Nu Vasive, Incorporated
Orthopedic · 140d
Cleared Apr 13, 2016
DICOM Viewer
K153653 · LLZ
Brainlab AG
Radiology · 114d
Cleared Apr 13, 2016
Varian Sterilization Boxes
K160021 · JAQ
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Apr 13, 2016
NormaTec Pulse and NormaTec Pulse Pro
K160608 · IRP
NormaTec Industries, LP
Physical Medicine · 41d
Cleared Apr 13, 2016
Neptune E-SEP Smoke Evacuation Pencil
K160693 · GEI
Stryker Corporation
General & Plastic Surgery · 30d
Cleared Apr 12, 2016
Orbit Infusion Set
K150921 · FPA
Ypsomed AG
General Hospital · 372d
Cleared Apr 12, 2016
icotec Pedicle System
K151977 · NKB
Icotec AG
Orthopedic · 270d
Cleared Apr 12, 2016
HealthChek Network Health Station
K152107 · DXN
Healthchek Network, LLC
Cardiovascular · 258d
Cleared Apr 12, 2016
All Poly Tibial Component
K152430 · JWH
United Orthopedic Corporation
Orthopedic · 230d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794 · EOX
Covidien, LLC
Ear, Nose, Throat · 197d
Cleared Apr 12, 2016
Superbium
K153229 · GEX
Bios S.R.L.
General & Plastic Surgery · 158d
Cleared Apr 12, 2016
TelioCAD Multi
K153753 · EBG
Ivoclar Vivadent, Inc.
Dental · 105d
Cleared Apr 12, 2016
EndoSize
K160376 · LLZ
Therenva Sas
Radiology · 62d
Cleared Apr 12, 2016
Arthrex iBalance BiCompartmental Arthroplasty System
K160461 · KRR
Arthrex, Inc.
Orthopedic · 53d
Cleared Apr 12, 2016
ARIES System
K160517 · OOI
Luminex Corporation
Microbiology · 48d
Cleared Apr 11, 2016
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA...
K152013 · LSW
Inova Diagnostics, Inc.
Immunology · 265d