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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83113–83136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 23, 2000
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
K000616 · MAI
Bionx Implants, Ltd.
Orthopedic · 28d
Cleared Mar 23, 2000
3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
K983826 · DXT
Unimachs Corp.
Cardiovascular · 511d
Cleared Mar 23, 2000
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
K992174 · DXC
Pilling Weck Surgical
Cardiovascular · 269d
Cleared Mar 23, 2000
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · MJN
Boston Scientific, Target
Cardiovascular · 174d
Cleared Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 171d
Cleared Mar 23, 2000
SOLAR 7/8000
K993757 · DSI
General Electric Medical Systems...
Cardiovascular · 139d
Cleared Mar 23, 2000
NARKOMED 6000
K993826 · MLC
Draeger Medical, Inc.
Cardiovascular · 132d
Cleared Mar 23, 2000
EP MEDSYSTEMS, EP-WORKMATE
K994011 · DQK
Ep Medsystems, Inc.
Cardiovascular · 118d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · JAK
Shimadzu Medical Systems
Radiology · 84d
Cleared Mar 22, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K994226 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 22, 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
K994339 · KGN
The Hymed Group Corp.
General & Plastic Surgery · 90d
Cleared Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
K994351 · LNH
Resonance Technology, Inc.
Radiology · 90d
Cleared Mar 22, 2000
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
K994352 · CAF
Hudson Respiratory Care, Inc.
Anesthesiology · 90d
Cleared Mar 22, 2000
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · HFM
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Mar 22, 2000
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
K994355 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
K000038 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
K000039 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
K000040 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
HARDYDISK, KANAMYCIN, 30MCG
K000203 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 21, 2000
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
K000229 · FCW
Videolabs, Inc.
Gastroenterology & Urology · 54d
Cleared Mar 21, 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · LCP
Genzyme Corp.
Hematology · 54d
Cleared Mar 21, 2000
HARDYDISK, CIPROFLOXACIN, 5MCG
K000258 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
HARDYDISK, CEFTAZIDIME, 30MCG
K000259 · JTN
Hardy Diagnostics
Microbiology · 53d