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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77401–77424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2002
T2 FEMORAL NAIL SYSTEM
K014220 · HSB
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
K014223 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 30d
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · MNH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jan 25, 2002
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400,...
K014294 · DQA
Medical Data Electronics
Anesthesiology · 28d
Cleared Jan 25, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · DZE
BioHorizons Implant Systems, Inc.
Dental · 10d
Cleared Jan 24, 2002
ANCURE SHEATH MODEL # 40315, 40320, 40325
K003889 · DYB
Guidant Cardiac and Vascular Surgery
Cardiovascular · 402d
Cleared Jan 24, 2002
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
K011185 · DJC
Psychemedics Corp.
Toxicology · 281d
Cleared Jan 24, 2002
MULTI-SNARE SET
K011783 · DXE
Pfm Produkte Fur Die Medizin AG
Cardiovascular · 231d
Cleared Jan 24, 2002
EPS320 CARDIAC STIMULATOR
K011826 · JOQ
Micropace Pty, Ltd.
Cardiovascular · 227d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d
Cleared Jan 24, 2002
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
K012749 · DQO
Biocardia, Inc.
Cardiovascular · 161d
Cleared Jan 24, 2002
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
K013120 · GZB
Medamicus, Inc.
Neurology · 128d
Cleared Jan 24, 2002
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY
K013636 · LNH
GE Medical Systems
Radiology · 80d
Cleared Jan 24, 2002
COALESCENT SURGICAL U-CLIP
K013664 · NCA
Coalescent Surgical
General & Plastic Surgery · 79d
Cleared Jan 24, 2002
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · EBG
Dmg USA, Inc.
Dental · 78d
Cleared Jan 24, 2002
SAFE
K013773 · HIS
Ssn Medical Products Sdn. Bhd.
Obstetrics & Gynecology · 72d
Cleared Jan 24, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K013899 · CDD
Ortho-Clinical Diagnostics
Toxicology · 62d
Cleared Jan 24, 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · KXK
Cp Medical
Radiology · 52d
Cleared Jan 24, 2002
HEMOCHRON JR. CITRATE APTT CUVETTE
K014008 · GFO
Itc, Inc.
Hematology · 50d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233 · LIP
Trinity Biotech, Plc
Microbiology · 29d
Cleared Jan 24, 2002
DELSONIC 2000
K014238 · ELC
Deldent , Ltd.
Dental · 29d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923 · MHX
Siemens Elema AB
Cardiovascular · 302d