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
145801–145824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1986
CARTOVAR BRAIN MAPPING ELECTRODIAGNOSTICS
K853420 · OLT
Alvar
Neurology · 177d
Cleared Feb 07, 1986
5.0 IOP & 7.5 IOP PROBES
K853432 · GXW
Diasonics, Inc.
Neurology · 176d
Cleared Feb 07, 1986
CODMAN LASER BACKSTOP
K853626 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 162d
Cleared Feb 07, 1986
CODMAN LASER RODS
K853627 · GEX
Codman & Shurtleff, Inc.
General & Plastic Surgery · 162d
Cleared Feb 07, 1986
KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE)
K853727 · LRX
Ryder Intl. Corp.
Ophthalmic · 154d
Cleared Feb 07, 1986
PRECIOUS LITE MODEL 4224
K854122 · LBI
E & B Technologies, Inc.
General Hospital · 121d
Cleared Feb 07, 1986
FIBEROPTIC COLLIMATING HANDPIECE
K854134 · GEX
Dawn Laser Technology, Inc.
General & Plastic Surgery · 120d
Cleared Feb 07, 1986
MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM
K854387 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
MODEL CO2 LASER SYSTEM 8B
K854398 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
MODEL 20-B CO2 LASER SYSTEM
K854399 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 99d
Cleared Feb 07, 1986
ACUSON NEEDLE GUIDE SYSTEM
K854429 · ITX
Acuson Computed Sonography
Radiology · 94d
Cleared Feb 07, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
K854470 · HHR
Minnesota Laser Corp.
Obstetrics & Gynecology · 93d
Cleared Feb 07, 1986
STORZ MVS 2.5MM/4.0MM,6.0MM INFUSION CANNULA
K854506 · HMX
Storz Instrument Co.
Ophthalmic · 87d
Cleared Feb 07, 1986
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · LXP
Storz Instrument Co.
Ophthalmic · 87d
Cleared Feb 07, 1986
I/A - VFE SYSTEM II
K854868 · HQE
Mira, Inc.
Ophthalmic · 65d
Cleared Feb 07, 1986
MICRO SURGICAL SYSTEM
K854871 · HQE
Mira, Inc.
Ophthalmic · 65d
Cleared Feb 07, 1986
NIDEK AC-2000 LASER SYSTEM
K860011 · HQB
Nidek, Inc.
Ophthalmic · 35d
Cleared Feb 07, 1986
ACROMED CANCELLOUS BONE SCREW
K860017 · HWC
Buckman Co., Inc.
Orthopedic · 35d
Cleared Feb 07, 1986
FISCHER WIRE/PIN CLAMP
K860018 · HXK
Buckman Co., Inc.
Orthopedic · 35d
Cleared Feb 07, 1986
WINK-EASE DISPOSABLE PROTECTIVE
K860043 · HQY
Eye Pro Medical Products, Inc.
Ophthalmic · 32d
Cleared Feb 07, 1986
SLUSH PAN COVER
K860065
O.R. Concepts, Inc.
General & Plastic Surgery · 32d
Cleared Feb 07, 1986
VIS-2000 VIDEO SYSTEM
K860173 · FWG
Vistek Corp.
General & Plastic Surgery · 21d
Cleared Feb 06, 1986
MEVASSIST(SETUP CONTROLLER)
K852609 · IYE
Magus Microcontrollers, Inc.
Radiology · 232d
Cleared Feb 06, 1986
CARDIMAX FX-1164
K853979 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 133d