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
31729–31752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2016
Repagyn vaginal suppositories
K153372 · NUC
Farma-Derma S.R.L.
Obstetrics & Gynecology · 220d
Cleared Jun 30, 2016
VITA ENAMIC Implant Solutions (IS)
K153645 · NHA
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 192d
Cleared Jun 30, 2016
STERIZONE Sterilizer
K153689 · PJJ
Tso3, Inc.
General Hospital · 190d
Cleared Jun 30, 2016
RTHawk, HeartVista Cardiac Package
K153740 · LNH
Heartvista, Inc.
Radiology · 185d
Cleared Jun 30, 2016
3 Series Phototherapy Unit
K153749 · FTC
Daavlin Distributing Company
General & Plastic Surgery · 184d
Cleared Jun 30, 2016
ViaValve Safety I.V. Catheter
K160235 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 150d
Cleared Jun 30, 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · ELW
Kerr Corporation
Dental · 134d
Cleared Jun 30, 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · HIS
Lelo, Inc.
Obstetrics & Gynecology · 115d
Cleared Jun 30, 2016
Relizorb
K161247 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
K161495 · OOI
Luminex Corporation
Microbiology · 29d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
Arthrosurface Bone Screws
K161539 · HWC
Arthrosurface, Inc.
Orthopedic · 27d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A...
K161556 · OZE
Centers For Disease Control and...
Microbiology · 24d
Cleared Jun 29, 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)...
K151986 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 348d
Cleared Jun 29, 2016
Spinal Jaxx Interbody Fusion Device
K152501 · MAX
Neuropro Spinaljaxx, Inc.
Orthopedic · 302d
Cleared Jun 29, 2016
Lite Touch
K152737 · GEX
Focus Medical, LLC
General & Plastic Surgery · 280d
Cleared Jun 29, 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · MNI
Medacta International S.A.
Orthopedic · 230d
Cleared Jun 29, 2016
ADMIRE
K153360 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 222d
Cleared Jun 29, 2016
BloodSTOP iX Battle Matrix
K160130 · QSY
Lifescience Plus, Inc.
General & Plastic Surgery · 161d
Cleared Jun 29, 2016
Nustat XR
K160578 · QSY
Beeken Biomedical, LLC
General & Plastic Surgery · 120d
Cleared Jun 29, 2016
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
K160752 · LFL
Ethicon Endo-Suregery, LLC
General & Plastic Surgery · 103d
Cleared Jun 29, 2016
ally Liquid Personal Lubricant
K160763 · NUC
Private Label Production, LLC
Obstetrics & Gynecology · 100d
Cleared CT Jun 29, 2016
Vent-Os Sinus Dilation family
K160770 · LRC
Sinusys Corporation
Ear, Nose, Throat · 100d