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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71137–71160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2003
MITEK MICRO QUICKANCHOR
K032078 · NOV
Mitek Worldwide
Orthopedic · 49d
Cleared Aug 25, 2003
STARBOND DENTAL BONDING ALLOYS
K032106 · EJT
Star Refining Precious Metals South...
Dental · 48d
Cleared Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203 · GKR
Hemocue, Inc.
Hematology · 38d
Cleared Aug 25, 2003
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
K032341 · EIA
Sota Precision Optics, Inc.
Dental · 27d
Cleared Aug 25, 2003
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
K032415 · MOS
Usa Instruments, Inc.
Radiology · 20d
Cleared Aug 25, 2003
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
K032474 · MOS
Usa Instruments, Inc.
Radiology · 13d
Cleared Aug 25, 2003
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
K032500 · KPS
Eclipse Systems, Inc.
Radiology · 12d
Cleared Aug 22, 2003
ANKYLOS
K012681 · DZE
Dentsply Ceramco
Dental · 738d
Cleared Aug 22, 2003
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · MGQ
Medtrade Products , Ltd.
General & Plastic Surgery · 382d
Cleared Aug 22, 2003
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
K023400 · HPZ
Fci Ophthalmics, Inc.
Ophthalmic · 317d
Cleared Aug 22, 2003
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
K030860 · KLI
Monobind
Chemistry · 157d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · HWC
Osteomed LP
Orthopedic · 133d
Cleared Aug 22, 2003
TRAXIS CEMENT RESTRICTOR
K031318 · JDK
Spinal Concepts, Inc.
Orthopedic · 119d
Cleared Aug 22, 2003
INNOVA 3100
K031637 · OWB
GE Medical Systems
Radiology · 87d
Cleared Aug 22, 2003
INTERMED ZOOM COLPOSCOPE
K031639 · HEX
Intermed Group, Inc.
Obstetrics & Gynecology · 87d
Cleared Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
K031657 · MRW
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K031692 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 81d
Cleared Aug 22, 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · FRN
Medtronic Minimed
General Hospital · 53d
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · LEG
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 22, 2003
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
K032068 · DTR
Cardiovention, Inc.
Cardiovascular · 50d
Cleared Aug 22, 2003
Trellis Reserve Infusion System
K032261 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 30d
Cleared Aug 22, 2003
VERSATREK
K032306 · MDB
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 22, 2003
ALTATEC CERAMIC ABUTMENT
K032448 · NHA
Altatec Biotechnologies
Dental · 14d