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
64705–64728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGG II
K052142 · MST
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGA II
K052143 · MST
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Oct 04, 2005
MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A
K052164 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 56d
Cleared Oct 04, 2005
FETAL MONITOR, MODELS BT-300 AND BT-200
K052190 · HGM
Bistos Co., Ltd.
Obstetrics & Gynecology · 54d
Cleared Oct 04, 2005
CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
K052430 · KPS
Digirad Corp.
Radiology · 28d
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Oct 03, 2005
FIDIS CONNECTIVE 8
K050286 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 238d
Cleared Oct 03, 2005
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · KHE
Epitope Diagnostics, Inc.
Hematology · 90d
Cleared Oct 03, 2005
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS,...
K051872 · EFB
Mk-Dent GmbH
Dental · 84d
Cleared Oct 03, 2005
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE)
K051969 · CHQ
Ibl GmbH
Chemistry · 75d
Cleared Oct 03, 2005
ISE COMPENSATOR
K052193 · JIT
Roche Diagnostics
Chemistry · 53d
Cleared Oct 03, 2005
ADVIA CHEMISTRY MICROALBUMIN CONTROLS
K052242 · JJW
Bayer Healthcare, LLC
Chemistry · 47d
Cleared Oct 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
K052269 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Oct 03, 2005
IBL CORTISOL LIA TEST KIT
K052359 · CGR
Lehnus & Associates Consulting
Chemistry · 38d
Cleared Oct 03, 2005
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140,...
K052516 · JOJ
Steritec Products, Inc.
General Hospital · 19d
Cleared Sep 30, 2005
HEMOR-RITE CRYOTHERAPHY
K042564 · LKX
Fama Holdings International Corp
Gastroenterology & Urology · 374d
Cleared Sep 30, 2005
TECHNO-SCOPE VISUAL STETHOSCOPE
K050097 · DQD
Techtrade, LLC
Cardiovascular · 259d
Cleared Sep 30, 2005
ANDROFLOW - RESPIRATORY RATE MONITOR
K051779 · BZQ
Andromed, Inc.
Anesthesiology · 91d
Cleared Sep 30, 2005
VISANTE OCT
K051789 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 91d
Cleared Sep 30, 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051913 · LYY
Shinemound Enterprise, Inc.
General Hospital · 77d
Cleared Sep 30, 2005
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT,...
K051944 · HQF
Lumenis, Inc.
Ophthalmic · 74d
Cleared Sep 30, 2005
HUANQIU HEATING LAMP
K052063 · ILY
A & A Medical Supplies, Inc.
Physical Medicine · 63d
Cleared Sep 30, 2005
IPLAN RT FIBERTRACKING
K052220 · IYE
Brainlab AG
Radiology · 46d
Cleared Sep 30, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
K052250 · LON
Becton, Dickinson & CO
Microbiology · 43d