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
41377–41400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2013
MYVISIONTRACK(TM)
K121738 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 254d
Cleared Feb 22, 2013
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K121795 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 248d
Cleared Feb 22, 2013
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS,...
K122015 · KRO
Howmedica Osteonics Corp.
Orthopedic · 227d
Cleared Feb 22, 2013
U-MOTION II ACETABULAR SYSTEM
K122185 · LZO
United Orthopedic Corp.
Orthopedic · 214d
Cleared Feb 22, 2013
MAMMOMAL INSPIRATION
K122286 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 207d
Cleared Feb 22, 2013
T:CONNECT DATA MANAGEMENT SYSTEM
K122361 · OUG
Tandem Diabetes Care, Inc.
General Hospital · 203d
Cleared Feb 22, 2013
VPULSE
K122640 · JOW
Cothera, LLC
Cardiovascular · 177d
Cleared Feb 22, 2013
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
K122720 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 170d
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727 · LZA
Northstar Healthcare Holdings
General Hospital · 170d
Cleared Feb 22, 2013
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA...
K123187 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 134d
Cleared Feb 22, 2013
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
K123459 · MBH
Zimmer, Inc.
Orthopedic · 105d
Cleared Feb 22, 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615 · EIH
Dentsply Intl.
Dental · 91d
Cleared Feb 22, 2013
EMORY CARDIAC TOOLBOX 4.0
K123646 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · MOS
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Feb 22, 2013
EOS
K123740 · MQB
Eos Imaging
Radiology · 79d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Feb 22, 2013
MRI PATIENT MONITORING SYSTEM (MODEL 865214)
K124061 · MWI
Invivo Corporation
Cardiovascular · 53d
Cleared Feb 22, 2013
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
K130058 · IYN
Olympus Medical Systems Corp.
Radiology · 44d
Cleared Feb 22, 2013
PERSONA NATURAL TIBIA BASEPLATES
K130143 · JWH
Zimmer, Inc.
Orthopedic · 31d
Cleared Feb 21, 2013
COMFORT COUGH
K113549 · NHJ
Seoil Pacific Corp.
Anesthesiology · 448d
Cleared Feb 21, 2013
FIN-S MICROIMPLANT
K120861 · OAT
Creekside Orthodontics
Dental · 336d
Cleared Feb 21, 2013
FIBER DISK AND BLOCK PERMANENT, TRINIA
K121735 · EBF
Bioloren S.R.L.
Dental · 253d
Cleared Feb 21, 2013
EMBLETTA MPR
K122516 · MNR
Embla Systems
Anesthesiology · 188d
Cleared Feb 21, 2013
LUCENT
K122967 · MAX
Spinal Elements, Inc.
Orthopedic · 149d