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

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176,076 results
156961–156984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1983
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG
K831271 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 98d
Cleared Jul 26, 1983
SOLARCRYL CUSTOM TRAY MATERIAL
K831293 · EBH
Solar Dental Co., Inc.
Dental · 97d
Cleared Jul 26, 1983
POLYCHACO FIA-ABS TEST FOR SYPHILIS
K831296 · JWL
Parasitic Disease Consultants
Immunology · 97d
Cleared Jul 26, 1983
COAXIAL BALLOON URETHRAL DILATOR
K831384 · FAH
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 89d
Cleared Jul 26, 1983
AVL 0073 MICROSAMPLER
K831395 · FMI
Avl Scientific Corp.
General Hospital · 88d
Cleared Jul 26, 1983
ULTRA PULSATOR
K831472
Medelco , Ltd.
Physical Medicine · 81d
Cleared Jul 26, 1983
ULTRA PULSATOR MF
K831473 · IPF
Medelco , Ltd.
Physical Medicine · 81d
Cleared Jul 26, 1983
MINI PULSATOR
K831474
Medelco , Ltd.
Physical Medicine · 81d
Cleared Jul 26, 1983
HEATING BLOCK MICROELISA SYSTEM
K831642 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
STRIPREADER MICROELISA SYSTEM
K831643 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
TEMP. BIPOLAR EPICARDIAL LEAD
K831645 · LDF
Cordic Corp.
Cardiovascular · 64d
Cleared Jul 26, 1983
MICROELISA COMP
K831658 · LIB
Organon Teknika Corp.
Chemistry · 64d
Cleared Jul 26, 1983
AMOXAPINE 8-HYDRO-XYAMOXAPINE
K831734 · DIF
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
MAPROTILINE
K831735 · LAS
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
CAFFINE TOXICOLOGY CONTROL
K831738 · LAS
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
FLURAZEPAM TOXICOLOGY CONTROL
K831741 · DIF
Utak Laboratories, Inc.
Toxicology · 56d
Cleared Jul 26, 1983
PM-3
K831750 · DXS
Delta Medical Industries
Cardiovascular · 55d
Cleared Jul 26, 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767 · DTB
Oscor, Inc.
Cardiovascular · 55d
Cleared Jul 26, 1983
EGG YOLK AGAR
K831827 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 49d
Cleared Jul 26, 1983
UNIVERSAL LEVEL SENSOR
K831879 · DTW
3M Health Care, Sarns
Cardiovascular · 43d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · DTB
Medtronic Vascular
Cardiovascular · 27d
Cleared Jul 26, 1983
HEARING AID G3H & G3T
K832129 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jul 26, 1983
CIRCUT 1
K832147
Brimfield Scientific Instruments
General & Plastic Surgery · 26d
Cleared Jul 26, 1983
DELTA CONDUCTIVE ADHESIVE ELECTROSURG-
K832157 · GEI
Delta Medical Electronics, Inc.
General & Plastic Surgery · 21d