FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
42313–42336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2012
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · NHB
Medtronic Xomed
Ear, Nose, Throat · 82d
Cleared Oct 31, 2012
MODIFIED TREVO RETRIEVER
K122478 · NRY
Concentric Medical, Inc.
Neurology · 78d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · KLW
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Oct 30, 2012
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · KWD
Biopro, Inc.
Orthopedic · 117d
Cleared Oct 26, 2012
LEGACY-500
K111588 · JFB
Mt Tables, LLC
Physical Medicine · 507d
Cleared Oct 26, 2012
THE CANARY SYSTEM
K112139 · NBL
Quantum Dental Technologies, Inc.
Dental · 458d
Cleared Oct 26, 2012
SPERMFREEZE SOLUTION
K113786 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 309d
Cleared Oct 26, 2012
SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL...
K120127 · KOB
Swan Valley Medical, Incorporated
Gastroenterology & Urology · 283d
Cleared Oct 26, 2012
ZOLL FULLY AUTOMATIC AED PLUS
K120406 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 260d
Cleared Oct 26, 2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
K120796 · JAK
Superdimension, Inc.
Radiology · 225d
Cleared Oct 26, 2012
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL...
K120930 · FRO
Medtrade Products , Ltd.
General & Plastic Surgery · 213d
Cleared Oct 26, 2012
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
K121201 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 190d
Cleared Oct 26, 2012
FLOW2, SWING
K121561 · ILK
Thyssenkrupp Accessibility B.V.
Physical Medicine · 150d
Cleared Oct 26, 2012
ECHONAVIGATOR RELEASE 1
K121781 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 130d
Cleared Oct 26, 2012
RENEW INSERT
K122003 · PBP
Renew Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 26, 2012
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY...
K122137 · IYE
Accuray Incorporated
Radiology · 100d
Cleared Oct 26, 2012
NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
K122215 · FRN
Carticept Medical, Inc.
General Hospital · 93d
Cleared Oct 26, 2012
SKINTEMP II
K122325 · KGN
Human Biosciences, Inc.
General & Plastic Surgery · 86d
Cleared Oct 26, 2012
LIQUIDBAND FLOW CONTROL
K122446 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 77d
Cleared Oct 26, 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · LCP
Bio-Rad Laboratories, Inc., Clinical...
Chemistry · 73d
Cleared Oct 26, 2012
ABL90 FLEX
K122642 · CHL
Radiometer Medical Aps
Chemistry · 58d
Cleared Oct 26, 2012
COLUMBUS REVISION KNEE SYSTEM
K122985 · JWH
Aesculap Implant System, Inc.
Orthopedic · 30d
Cleared Oct 26, 2012
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
K123001 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024 · DQX
Boston Scientific Corporation
Cardiovascular · 28d