FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
25561–25584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2018
OVOMotion Shoulder Arthroplasty System
K173964 · HSD
Arthrosurface, Inc.
Orthopedic · 110d
Cleared Apr 18, 2018
RAILWAY Sheathless Access System
K180081 · DYB
Cordis Corporation
Cardiovascular · 97d
Cleared Apr 18, 2018
Genistrong
K180836 · GCJ
Genicon, Inc.
General & Plastic Surgery · 19d
Cleared Apr 18, 2018
VERTEX™ Reconstruction System
K180851 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Apr 17, 2018
Fusion OMNI Sphincterotome
K172288 · KNS
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 260d
Cleared Apr 17, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm,...
K172610 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 229d
Cleared Apr 17, 2018
WR19 System
K172735 · GWQ
Zeto, Inc.
Neurology · 218d
Cleared Apr 17, 2018
DiLumen C2
K173317 · FDF
Lumendi, LLC
Gastroenterology & Urology · 180d
Cleared Apr 17, 2018
Penumbra Coil 400, Ruby Coil System, POD System
K173614 · HCG
Penumbra, Inc.
Neurology · 146d
Cleared Apr 17, 2018
NM/CT 850, NM/CT 860
K173816 · KPS
Ge Healthcare
Radiology · 123d
Cleared Apr 17, 2018
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
K180078 · MAX
Innovasis, Inc.
Orthopedic · 97d
Cleared Apr 17, 2018
KARL STORZ ICG Imaging System
K180146 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 89d
Cleared Apr 17, 2018
Diode laser hair removal device
K180353 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 68d
Cleared Apr 17, 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy...
K180416 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 61d
Cleared Apr 17, 2018
FOCUS Pedicle Screw System
K180458 · NKB
Nvision Biomedical Technologies, LLC
Orthopedic · 56d
Cleared Apr 17, 2018
FAST1™ Intraosseous Infusion System
K180588 · FMI
Teleflex Medical
General Hospital · 42d
Cleared Apr 17, 2018
PreludeSYNC DISTAL Radial Compression System
K180723 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Apr 17, 2018
Aesculap Slim Clip Applier
K180914 · HCI
Aesculap, Inc.
Neurology · 8d
Cleared Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
K171603 · FAD
Cook Incorporated
Gastroenterology & Urology · 319d
Cleared Apr 16, 2018
Hemoclip
K172727 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Apr 16, 2018
CardiMax Electrocardiograph
K173226 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 195d
Cleared Apr 16, 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6,...
K173726 · DHB
Phadia AB
Immunology · 132d
Cleared Apr 16, 2018
Mediant Anterior Cervical Plating System
K173935 · KWQ
Intelligent Implant Systems, LLC
Orthopedic · 111d
Cleared Apr 16, 2018
GDT-1000 System
K180096 · HIH
Acuvu, Inc.
Obstetrics & Gynecology · 90d