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
80281–80304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Apr 06, 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
K010883 · ITX
Teratech Corp.
Radiology · 14d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Apr 05, 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
K002617 · HIR
Neen Design , Ltd.
Gastroenterology & Urology · 225d
Cleared Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
K002892 · FKX
Fresenius Medical Care North America
Gastroenterology & Urology · 202d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE...
K003350 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 161d
Cleared Apr 05, 2001
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
K003701 · JOW
Sentech Medical Systems, Inc.
Cardiovascular · 125d
Cleared Apr 05, 2001
NUVOLASE 532 MEDICAL LASER SYSTEM
K010046 · GEX
American Laser Corp.
General & Plastic Surgery · 90d
Cleared Apr 05, 2001
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
K010129 · LNI
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Apr 05, 2001
VERSALUX
K010133 · EBZ
Centrix, Inc.
Dental · 78d
Cleared Apr 05, 2001
TOTAL CURE
K010196 · EBF
Bisco, Inc.
Dental · 73d
Cleared Apr 05, 2001
PJUR EROS WATER FORMULATION
K010199 · NUC
L.C.C. Pjur Group Germany
Obstetrics & Gynecology · 73d
Cleared Apr 05, 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · DCK
Beckman Coulter, Inc.
Immunology · 70d
Cleared Apr 05, 2001
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
K010377 · KZH
Minimed, Inc.
General Hospital · 56d
Cleared Apr 05, 2001
VERDICT -II BAR/BZO
K010561 · DIS
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · DKZ
Medtox Diagnostics, Inc.
Toxicology · 38d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Apr 05, 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · LHI
Bioject, Inc.
General Hospital · 34d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9068 T
K010653 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TEST, MODEL 9078 T
K010654 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · MVO
Phamatech
Toxicology · 31d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 30d
Cleared Apr 05, 2001
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
K010829 · LYZ
General Gloves Corp.
General Hospital · 16d
Cleared Apr 05, 2001
THE LIBERATOR WHEELCHAIR
K010859 · ITI
Liberator Wheelchairs, Inc.
Physical Medicine · 14d