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
61537–61560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2006
SPECTRA SYSTEM
K061319 · DZE
Implant Direct, LLC
Dental · 141d
Cleared Sep 29, 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732,...
K061568 · JXG
Codman & Shurtleff, Inc.
Neurology · 115d
Cleared Sep 29, 2006
MINI-YAG LASER
K061850 · GEX
American Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Sep 29, 2006
ZIRKONZAHN ICE
K061851 · EIH
Zirkonzahn GmbH
Dental · 91d
Cleared Sep 29, 2006
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · FLL
Ge Healthcare
General Hospital · 81d
Cleared Sep 29, 2006
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K062095 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 67d
Cleared Sep 29, 2006
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
K062242 · LAF
Lin-Zhi International, Inc.
Chemistry · 58d
Cleared Sep 29, 2006
DLM112 DAYLINK MONITOR
K062304 · DRG
Rtx Healthcare A/S
Cardiovascular · 52d
Cleared Sep 29, 2006
ARTHREX ASPIRATE KIT
K062365 · FMF
Arthrex, Inc.
General Hospital · 46d
Cleared Sep 29, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
K062428 · NQN
Tripath Imaging, Inc.
Pathology · 42d
Cleared Sep 29, 2006
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
K062462 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 36d
Cleared Sep 29, 2006
VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901
K062501 · JJX
Maine Standards Co.
Chemistry · 35d
Cleared Sep 29, 2006
DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM...
K062576 · MHX
Ge Healthcare
Cardiovascular · 29d
Cleared Sep 29, 2006
XPLORER 1600 PLUS
K062586 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Sep 29, 2006
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
K062654 · MBH
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Sep 29, 2006
GLADIATOR BIPOLAR SYSTEM
K062693 · KWY
Wrightmedicaltechnologyinc
Orthopedic · 18d
Cleared Sep 29, 2006
MAXIFLEX-SEMI FLEX SCOPE
K062725 · FGB
Technology Delivery Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Sep 29, 2006
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM
K062747 · HRS
Arthrex, Inc.
Orthopedic · 15d
Cleared Sep 28, 2006
CYTORI CELUTION CELL CONCENTRATION DEVICE
K060482 · CAC
Cytori Therapeutics, Inc.
Anesthesiology · 217d
Cleared Sep 28, 2006
STRYKER URETERAL ILLUMINATION SYSTEM IV
K061548 · FCS
Stryker Corp.
Gastroenterology & Urology · 115d
Cleared Sep 28, 2006
MP-1 MICROPERIMETER
K061768 · HKI
Nidek Technologies Srl
Ophthalmic · 97d
Cleared Sep 28, 2006
V-2200 INFANT INCUBATOR
K061856 · FMZ
Atom Medical, Inc.
General Hospital · 90d
Cleared Sep 28, 2006
CLEARFIL CERAMIC PRIMER
K061906 · EBF
Kuraray Medical, Inc.
Dental · 85d
Cleared Sep 28, 2006
PROMETEY, MODEL G1-03
K062071 · GEX
Spectrum International
General & Plastic Surgery · 69d