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
33025–33048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2016
AirLife Infant Single Limb Heated Wire Circuit
K151959 · BZE
Carefusion, Inc.
Anesthesiology · 188d
Cleared Jan 20, 2016
Medtronic Transportation/Sterilization Cassettes
K152241 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 163d
Cleared Jan 20, 2016
Pentacam AXL
K152311 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 159d
Cleared Jan 20, 2016
Stereo 3D option for Vision Applications
K152352 · LLZ
GE Medical Systems SCS
Radiology · 153d
Cleared Jan 20, 2016
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
K152463 · FWP
Poriferous, LLC
General & Plastic Surgery · 145d
Cleared Jan 20, 2016
CAS-One IR
K152473 · JAK
Cascination AG
Radiology · 142d
Cleared Jan 20, 2016
Stroke VCAR
K152584 · JAK
GE Medical Systems SCS
Radiology · 132d
Cleared Jan 20, 2016
Venus Versa System
K152790 · ONF
Venus Concept , Ltd.
General & Plastic Surgery · 117d
Cleared Jan 20, 2016
SonoSite Edge II Ultrasound System
K153626 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 33d
Cleared Jan 20, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort...
K153642 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 20, 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K153643 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 30d
Cleared Jan 20, 2016
basixTOUCH40 Inflation Syringe
K153672 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 20, 2016
PleuraFlow System
K153681 · OTK
Clearflow, Inc.
General & Plastic Surgery · 29d
Cleared Jan 19, 2016
Lustre PRO Light System
K143713 · GEX
Ambicare Health, Ltd.
General & Plastic Surgery · 386d
Cleared Jan 19, 2016
Phadia Prime
K151029 · DHB
Phadia AB
Immunology · 277d
Cleared Jan 19, 2016
Hospira Extension Sets
K151969 · FPA
Icu Medical, Inc.
General Hospital · 187d
Cleared Jan 19, 2016
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
K152215 · EBG
Dentalplus GmbH
Dental · 165d
Cleared Jan 19, 2016
True Flow Valvuloplasty Perfusion Catheter
K152613 · OZT
C.R. Bard, Inc.
Cardiovascular · 127d
Cleared Jan 19, 2016
Unison-C Anterior Cervical Fixation System
K152793 · OVE
Pioneer Surgical Technology, Inc....
Orthopedic · 113d
Cleared Jan 19, 2016
Flo Trac sensor, Volume View sensor
K152980 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Jan 19, 2016
Epic Extremity Cannulated Screw System
K153333 · HWC
Epic Extremity, LLC
Orthopedic · 61d
Cleared Jan 19, 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK...
K153373 · ODP
Medtronic Sofamor Danek
Orthopedic · 57d
Cleared Jan 19, 2016
Capillus202
K153618 · OAP
Capillus, LLC
General & Plastic Surgery · 32d
Cleared Jan 19, 2016
M.U.S.T. Pedicle Screw System
K153664 · NKB
Medacta International
Orthopedic · 29d