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
78985–79008 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2001
3T L. V. CONTROL VALVE
K001245 · MJJ
3t Medical Systems, LLC
Cardiovascular · 484d
Cleared Aug 15, 2001
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL...
K002992 · IKT
Medtronic Functional Diagnostics A/S
Neurology · 324d
Cleared Aug 15, 2001
NURSE'S ASSISTANT O.R. CONTROL SYSTEM
K010754 · GCJ
Valmed Corp.
General & Plastic Surgery · 155d
Cleared Aug 15, 2001
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · JOH
Rusch Intl.
Anesthesiology · 118d
Cleared Aug 15, 2001
AMEDA HYGIENIKIT
K011519 · HGY
Hollister, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · LYA
Seikagaku Corp.
Ear, Nose, Throat · 89d
Cleared Aug 15, 2001
VHS PEDIATRIC HIP SCREW SYSTEM
K011603 · KTT
Walter Abendschein, M.D.
Orthopedic · 83d
Cleared Aug 15, 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
K011679 · POV
Embryotech Laboratories, Inc.
Hematology · 77d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 30d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212 · KWS
Tornier
Orthopedic · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
United States Surgical, A Division of...
Orthopedic · 27d
Cleared Aug 15, 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Aug 15, 2001
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
K012391 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
K012394 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
K012395 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 19d
Cleared Aug 15, 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT...
K991822 · DZE
Dr. Ihde Dental AG Switzerland
Dental · 811d
Cleared Aug 14, 2001
NORMED MANDIBULAR FIXATION SYSTEM
K010118 · JEY
Osteomedics, Inc.
Dental · 210d
Cleared Aug 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC,...
K010399 · MSD
Diatek, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504 · JDS
Baumer, S.A
Orthopedic · 90d
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
SURE CHECK PREGNANCY TEST
K011551 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
MODEL 235GE-64
K011608 · MOS
Medical Advances, Inc.
Radiology · 81d
Cleared Aug 14, 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 71d