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
81457–81480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 19, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
K001936 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · FFK
Boston Scientific Corp
Gastroenterology & Urology · 9d
Cleared Jul 19, 2000
CONTROL SOLUTIONS INC, MODEL CS3101
K993420 · IPF
Control Solutions, Inc.
Physical Medicine · 281d
Cleared Jul 19, 2000
SPINAL PAD
K993684 · ILY
Bioscan, Inc.
Physical Medicine · 261d
Cleared Jul 19, 2000
NANMA VACUUM PUMP
K993909 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 245d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214 · JWH
Kinamed, Inc.
Orthopedic · 218d
Cleared Jul 18, 2000
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
K001298 · IOR
Roll-Ability (Pty) , Ltd.
Physical Medicine · 85d
Cleared Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359 · DSI
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 71d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K001843 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Jul 18, 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K001964 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d
Cleared Jul 18, 2000
CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
K992182 · GCJ
Ca Guard, Ltd.
General & Plastic Surgery · 386d
Cleared Jul 18, 2000
SURGILIGHT, INC EXCIMER LASER
K993328 · GEX
Surgilight, Inc.
General & Plastic Surgery · 288d
Cleared Jul 18, 2000
BIOPACK
K993685 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 18, 2000
LIGHT PATCH
K993686 · ILY
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 17, 2000
RIZA BAND STRETCHER (RBS)-60000
K001236 · FHN
R-Med, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 17, 2000
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
K001268 · MHX
General Electric Medical Systems...
Cardiovascular · 88d
Cleared Jul 17, 2000
MEDICAL IMAGE MERGE (MIM)
K001276 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Jul 17, 2000
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
K001296 · ITH
Cavendish Scott, Inc.
Physical Medicine · 84d
Cleared Jul 17, 2000
INTRODUCER SHEATH
K001328 · FEC
Novasys Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Jul 17, 2000
KARL STORZ 3D VIDEO SYSTEM
K001362 · GCI
Karl Storz Imaging, Inc.
General & Plastic Surgery · 80d