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
76273–76296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 2002
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K013507 · GZJ
Cosmo Health, Inc.
Neurology · 95d
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 25, 2002
PERICSCOPE, MODEL # PERISC1
K013576 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · DSY
Atrium Medical Corp.
Cardiovascular · 88d
Cleared Jan 25, 2002
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · BSP
B.Braun Medical, Inc.
Anesthesiology · 81d
Cleared Jan 25, 2002
FINGER JOINT PROSTHESIS
K013629 · KYJ
Avanta Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jan 25, 2002
RIBBOND - TRIAXIAL
K013881 · EBI
Ribbond, Inc.
Dental · 63d
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