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
35737–35760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2015
THD REVOLUTION
K141657 · JAF
Thd Spa
Radiology · 249d
Cleared Feb 24, 2015
AESCULAP ORTHOPILOT NEXT GENERATION
K141694 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 245d
Cleared Feb 24, 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula
K142296 · JOH
Covidien
Anesthesiology · 190d
Cleared Feb 24, 2015
MEGNA BREAST PUMPS
K142479 · HGX
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
Obstetrics & Gynecology · 173d
Cleared Feb 24, 2015
EAZY PRIMER
K142848 · KLE
Parkell, Inc.
Dental · 147d
Cleared Feb 24, 2015
Endoscope Sterilization Tray
K142937 · KCT
Intuitive Surgical, Inc.
General Hospital · 138d
Cleared Feb 24, 2015
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
K142956 · OMP
Integrated Healing Technologies
General & Plastic Surgery · 133d
Cleared Feb 24, 2015
Synergetics PHOTON EX
K143123 · MPA
Synergetics
Ophthalmic · 116d
Cleared Feb 24, 2015
Syngo X-workplace SW VD10
K143319 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 97d
Cleared Feb 24, 2015
Photonica Professional
K150336 · GEX
Ward Photonics, LLC
General & Plastic Surgery · 14d
Cleared Feb 23, 2015
SORRENTO BONE GRAFT SUBSTITUTE
K141429 · MQV
Haider Biologics, LLC
Orthopedic · 269d
Cleared Feb 23, 2015
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
K142128 · PNR
Covidien
Gastroenterology & Urology · 203d
Cleared Feb 23, 2015
Picosure Workstation
K143105 · GEX
Cynosure, Inc.
General & Plastic Surgery · 117d
Cleared Feb 23, 2015
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · OVE
Spineart
Orthopedic · 105d
Cleared Feb 23, 2015
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 102d
Cleared Feb 23, 2015
DentiAnn Smart Sil
K143382 · ELW
Seilglobal Co., Ltd.
Dental · 90d
Cleared Feb 23, 2015
Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR...
K143395 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 89d
Cleared Feb 23, 2015
Zimmer Periarticular Plating System
K150121 · HRS
Zimmer, Inc.
Orthopedic · 34d
Cleared Feb 23, 2015
Extremity Medical Suture Anchor
K150166 · MBI
Extremity Medical, LLC
Orthopedic · 28d
Cleared Feb 22, 2015
LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
K141246 · OUR
Life Spine, Inc.
Orthopedic · 284d
Cleared Feb 22, 2015
Talos-C(HA) Cervical Intervertebral Body Fusion Devices
K142345 · ODP
Meditech Spine, LLC
Orthopedic · 184d
Cleared Feb 20, 2015
PJ'S SERENITY
K132220 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 583d
Cleared Feb 20, 2015
CARRICELL
K132868 · MQV
Etex Corporation
Orthopedic · 525d
Cleared Feb 20, 2015
FIBERION OPHTHALMIC ENDOLASER PROBE
K133019 · HQF
Emtron Elektronik VE Mekanik Sanayi...
Ophthalmic · 512d