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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47665–47688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2011
OSTEOSCAF
K101827 · LYC
Texas Innovative Medical Devices...
Dental · 293d
Cleared Apr 20, 2011
SPI TITANIUM BASE FOR CAD/CAM
K102804 · NHA
Thommen Medical AG
Dental · 205d
Cleared Apr 20, 2011
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K102859 · HKI
Clarity Medical Systems
Ophthalmic · 202d
Cleared Apr 20, 2011
RESUSCITATION UNIT 105
K103317 · BZR
Atom Medical Corporation
Anesthesiology · 161d
Cleared Apr 20, 2011
NEOPIP PATIENT CIRCUIT WITH PEEP
K103833 · BYE
Neoforce Group, Inc.
Anesthesiology · 111d
Cleared Apr 20, 2011
CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
K110112 · FMF
Rongshan LI
General Hospital · 96d
Cleared Apr 20, 2011
SATURN 8000-GS
K110210 · MQB
New Medical Co., Ltd.
Radiology · 85d
Cleared Apr 20, 2011
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
K110436 · JJX
Fujirebio Diagnostics,Inc.
Chemistry · 64d
Cleared Apr 20, 2011
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX...
K110452 · LPL
Unilens Corp., USA
Ophthalmic · 63d
Cleared Apr 20, 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
K110461 · DQY
Biotronik, Inc.
Cardiovascular · 62d
Cleared Apr 20, 2011
UCP DRUG SCREENING TEST CUPS
K110515 · DIS
Ucp Biosciences, Inc.
Chemistry · 56d
Cleared Apr 20, 2011
JETSTREAM NAVITUS SYSTEM
K110626 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 47d
Cleared Apr 20, 2011
COMPUTED DENTAL RADIOGRAPHY
K110768 · MUH
Schick Technologies, Inc.
Radiology · 33d
Cleared Apr 20, 2011
CRE BALLOON DILATATION CATHETER
K110833 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 26d
Cleared Apr 20, 2011
SYMBIA.NET
K110844 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Apr 19, 2011
NATUS SLEEPWORKS, MODEL 104017
K090277 · OLZ
Excel-Tech Ltd. (Xltek)
Neurology · 804d
Cleared Apr 19, 2011
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
K093581 · JAK
Ge Medical Systems, LLC
Radiology · 517d
Cleared Apr 19, 2011
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K102034 · DZE
Blue Sky Bio, LLC
Dental · 274d
Cleared Apr 19, 2011
INJECTION PIPETTE
K102480 · MQH
Jieying Laboratory, Inc.
Obstetrics & Gynecology · 232d
Cleared Apr 19, 2011
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR
K103277 · FRC
3M Company-3M Health Care
General Hospital · 165d
Cleared Apr 19, 2011
CONSERVE BIO FOAM SHELL
K110029 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 104d
Cleared Apr 19, 2011
WEXLER VASCULAR CLAMP SERIES
K110148 · DXC
Microsurgical Laboratories,Inc.Dba...
Cardiovascular · 91d
Cleared Apr 19, 2011
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K110219 · LYZ
Wealth on (Jiangsu) Co., Ltd.
General Hospital · 84d
Cleared Apr 19, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110338 · LYZ
Zibo Yuechuan Plastic Products Co., Ltd.
General Hospital · 74d