FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
70633–70656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 22, 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA...
K032464 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 11d
Cleared Aug 22, 2003
SPIDERVIEW
K032466 · MWJ
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Aug 22, 2003
VIATRONIX V3D EXPLORER, REVISION 1.2
K032483 · LLZ
Viatronix, Inc.
Radiology · 10d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367 · JWH
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
K030574 · KMF
Glustitch, Inc.
General & Plastic Surgery · 178d
Cleared Aug 21, 2003
DENTAPORT ZX
K031204 · EKX
J. Morita USA, Inc.
Dental · 127d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · HRS
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735 · HNO
Ciba Vision Corporation
Ophthalmic · 78d