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
56161–56184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2008
INSULIN PROTECTOR
K073555 · IQG
Medicool, Inc.
General Hospital · 206d
Cleared Jul 11, 2008
ICI P AND S SERIES IR CAMERAS
K073581 · LHQ
Texas Infrared
Radiology · 204d
Cleared Jul 11, 2008
CARDIOSEN'C
K080047 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 185d
Cleared Jul 11, 2008
SOPRO 670 ARTHROSCOPIC PUMP
K080122 · HRX
Sopro
Orthopedic · 176d
Cleared Jul 11, 2008
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
K080666 · HCG
MicroVention, Inc.
Neurology · 123d
Cleared Jul 11, 2008
SERIM DISINTEK OPA TEST STRIP
K081370 · JOJ
Serim Research Corp.
General Hospital · 57d
Cleared Jul 11, 2008
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K081802 · ITX
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jul 11, 2008
CAPIMAGE
K081829 · IYX
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jul 11, 2008
MODIFICATION TO XYLOS SURGICAL MESH
K081882 · FTM
Xylos Corporation
General & Plastic Surgery · 9d
Cleared Jul 10, 2008
KEY LASER III 1243 US WITH DETECT
K073074 · GEX
Kavo America
General & Plastic Surgery · 253d
Cleared Jul 10, 2008
WELL LEAD REINFORCED ENDOTRACHEAL TUBE
K073383 · BTR
Well Lead Medical Instruments
Anesthesiology · 220d
Cleared Jul 10, 2008
VARIOSURG
K073678 · DZI
Nakanishi, Inc.
Dental · 195d
Cleared Jul 10, 2008
WATER WORKS DOUCHING DEVICE
K080200 · HED
Abbott Research Group, Inc.
Obstetrics & Gynecology · 167d
Cleared Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
K080739 · MKZ
Abbott Molecular, Inc.
Microbiology · 115d
Cleared Jul 10, 2008
ENSPLINT TM BONE SCREW
K080778 · HWC
Sonoma Orthopedic Products, Inc.
Orthopedic · 113d
Cleared Jul 10, 2008
LIPO CANNULA
K081039 · QPB
Millennium Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 10, 2008
ULTRACAPS S
K081273 · OIV
Sdi , Ltd.
Dental · 66d
Cleared Jul 10, 2008
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K081345 · JQC
Thermogenesis Corp.
Hematology · 57d
Cleared Jul 10, 2008
IMPROVED COMFORT-FIT NIGHTGUARD
K081669 · OBR
Den Tek Oral Care, Inc.
Dental · 27d
Cleared Jul 10, 2008
NUCLEUS-X, MODEL 230X
K081680 · DQY
NuMED, Inc.
Cardiovascular · 23d
Cleared Jul 10, 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Jul 09, 2008
SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
K070779 · NTB
Misonix, Inc.
General & Plastic Surgery · 476d
Cleared Jul 09, 2008
GENEX PUTTY
K073341 · MQV
Biocomposites, Ltd.
Orthopedic · 224d
Cleared Jul 09, 2008
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
K080097 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 177d