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
47593–47616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2011
AGACHAMBER SPACER
K101348 · NVP
Aga Plastic Ind. Com. Ltda.
Anesthesiology · 351d
Cleared Apr 29, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K103196 · LYZ
Changda Plastic Product Co., Ltd.
General Hospital · 182d
Cleared Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
K103343 · GZI
Bioness, Inc.
Neurology · 165d
Cleared Apr 29, 2011
PALAXPRESS ULTRA POWDER (PINK)
K110037 · EBI
Heraeus Kulzer, LLC
Dental · 113d
Cleared Apr 29, 2011
REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
K110253 · JOJ
Dana Products, Inc.
General Hospital · 91d
Cleared Apr 29, 2011
MAC 5500 HD, MAC 3500
K110266 · DPS
Ge Medical Systems Information...
Cardiovascular · 91d
Cleared Apr 29, 2011
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · FXX
Kimberly-Clark Corp.
General Hospital · 73d
Cleared Apr 29, 2011
FORTROSS BONE VOID FILLER
K110561 · MQV
Pioneer Surgical Technology
Orthopedic · 60d
Cleared Apr 29, 2011
PTS-X SIZING BALLOON CATHETER
K110903 · MJN
NuMED, Inc.
Cardiovascular · 29d
Cleared CT Apr 29, 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY...
K110909 · NTE
Abbott Laboratories
Cardiovascular · 29d
Cleared Apr 28, 2011
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
K101578 · JPK
R&D Systems, Inc.
Hematology · 325d
Cleared Apr 28, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102152 · LYZ
Hebei Tengda Plastic Co., Ltd.
General Hospital · 272d
Cleared Apr 28, 2011
AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
K102481 · NBW
Apex BioTechnology Corp.
Chemistry · 241d
Cleared Apr 28, 2011
ONE DAY FLAT PACK
K102895 · LPL
Menicon Co, Ltd.
Ophthalmic · 210d
Cleared Apr 28, 2011
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
K102957 · MAX
Cutting Edge Spine, LLC
Orthopedic · 205d
Cleared Apr 28, 2011
SPECTRA LASER SYSTEM
K103455 · GEX
Lutronic Corporation
General & Plastic Surgery · 156d
Cleared Apr 28, 2011
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
K103683 · JJX
Siemens Healthcare Diagnostics
Chemistry · 132d
Cleared Apr 28, 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758 · HCG
MicroVention, Inc.
Neurology · 126d
Cleared Apr 28, 2011
SECTRA MICRODOSE MAMMOGRAPHY
K110025 · MUE
Sectra-Imtec AB
Radiology · 115d
Cleared Apr 28, 2011
BD PEN NEEDLE
K110105 · FMI
Becton, Dickinson and Company (BD)
General Hospital · 105d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123 · HTY
Arthrex, Inc.
Orthopedic · 100d
Cleared Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
K110286 · ETW
Gn Otometrics A/S
Ear, Nose, Throat · 87d
Cleared Apr 28, 2011
FEMVUE SALINE-AIR DEVICE
K110288 · LKF
Femasys, Inc.
Obstetrics & Gynecology · 86d
Cleared Apr 28, 2011
VALO CORDLESS
K110582 · EBZ
Ultradent Products, Inc.
Dental · 58d