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
81673–81696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 27, 2000
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · LJT
Arrow Intl., Inc.
General Hospital · 31d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076 · MAI
Mitek Products
Orthopedic · 24d
Cleared Oct 26, 2000
PHOENIX DIGITAL EEG
K002316 · GWQ
Axon Systems, Inc.
Neurology · 87d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531 · LNH
Toshiba America Mri, Inc.
Radiology · 71d