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
80545–80568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2000
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
K002590 · LLZ
Cedara Software Corp.
Radiology · 71d
Cleared Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611 · LNH
GE Medical Systems
Radiology · 70d
Cleared Oct 31, 2000
ECAT PET SCANNER
K002715 · KPS
Cti Pet Systems, Inc.
Radiology · 61d
Cleared Oct 31, 2000
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
K002808 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
K002810 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
K002811 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
PLASMAKINETIC GENERATOR
K003060 · GEI
Everest Medical Corp.
General & Plastic Surgery · 29d
Cleared Oct 31, 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 29d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Oct 30, 2000
PBN FALLOPIAN TUBE CATHETER SYSTEM
K000620 · MDG
Medical Device Technologies, Inc.
Obstetrics & Gynecology · 249d
Cleared Oct 30, 2000
RESPONDER 3000
K000638 · MKJ
Ge Medical Systems Information...
Cardiovascular · 248d
Cleared Oct 30, 2000
CRANIOCAP
K000861 · MVA
Gillette Children'S Specialty Healthcare
Neurology · 227d
Cleared Oct 30, 2000
KSEA VASCULAR FIBERSCOPES
K001408 · LYK
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 179d
Cleared Oct 30, 2000
NIR BILIARY STENT
K002130 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 108d
Cleared Oct 30, 2000
SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB...
K002188 · DZE
Core-Vent Corp.
Dental · 102d
Cleared Oct 30, 2000
WUJIN #3 TIBIAL NAIL
K002325 · JDS
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Oct 30, 2000
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · KRR
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 30, 2000
ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
K002676 · DYB
Guidant Cardiac and Vascular Surgery
Cardiovascular · 63d
Cleared Oct 30, 2000
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
K003061 · KWQ
Synthes
Orthopedic · 28d
Cleared Oct 30, 2000
CORDIS SLALOM PTA BALLOON CATHETER
K003159 · LIT
Cordis Corp.
Cardiovascular · 20d
Cleared Oct 27, 2000
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
K000317 · GEX
Tissue Medical Lasers, Inc.
General & Plastic Surgery · 269d
Cleared Oct 27, 2000
SUPER NOVA, ACUBEAM
K001179 · ILY
Light Force Therapy, Inc.
Physical Medicine · 199d
Cleared Oct 27, 2000
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
K001972 · MSX
Visicu, Inc.
Cardiovascular · 121d
Cleared Oct 27, 2000
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 80d