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
77857–77880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784 · DSI
Mennen Medical , Ltd.
Cardiovascular · 69d
Cleared Aug 16, 2001
FUTURA TOPCAP NON GAMMA-2
K011801 · EJJ
Ab Ardent
Dental · 69d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Aug 16, 2001
IMAGINE H.E.
K012156 · EIH
Wieland Edelmetalle GmbH & Co.
Dental · 36d
Cleared Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS...
K012242 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 16, 2001
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
K012379 · IZL
Trex Enterprises Corp.
Radiology · 21d
Cleared Aug 16, 2001
ABN ANEROID SPHYGMOMANOMETER
K012444 · DXQ
Pt. Sugih Instrumendo Abadi
Cardiovascular · 15d
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