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
66961–66984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2005
PANTHERA N POWDER FREE BLACK NITRILE GLOVES
K042898 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 90d
Cleared Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · KTT
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 18, 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · JDR
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Jan 18, 2005
MEDIN TECH ZIRCONIA-CP10, SS1000
K043472 · EIH
Medin Tech
Dental · 33d
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · CDT
Dade Behring, Inc.
Chemistry · 26d
Cleared Jan 14, 2005
X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
K033900 · FRO
Noble Fiber Technologies
General & Plastic Surgery · 394d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168 · NDN
Globus Medical, Inc.
Orthopedic · 158d
Cleared Jan 14, 2005
DEVILBISS NASAL CPAP MASK, 9354 SERIES
K042455 · BZD
Sunrise Medical
Anesthesiology · 126d
Cleared Jan 14, 2005
TITAN DENTAL IMPLANT SYSTEM
K042971 · DZE
Titan Implants, Inc.
Dental · 78d
Cleared Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
K043252 · JDQ
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jan 14, 2005
TRIMED OSTEOTOMY PLATE
K043263 · HRS
TriMed, Inc.
Orthopedic · 51d
Cleared Jan 14, 2005
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K043304 · LHI
Bioject Medical Technologies, Inc.
General Hospital · 45d
Cleared Jan 14, 2005
THERMAGE THERMACOOL SYSTEM
K043402 · GEI
Thermage, Inc.
General & Plastic Surgery · 35d
Cleared Jan 14, 2005
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
K043502 · LJS
C.R. Bard, Inc.
General Hospital · 25d
Cleared Jan 14, 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · KWP
Custom Spine, Inc.
Orthopedic · 25d
Cleared Jan 14, 2005
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
K043536 · HAW
Orthosoft, Inc.
Neurology · 23d
Cleared Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
K043537 · LPH
Biomet, Inc.
Orthopedic · 23d
Cleared Jan 14, 2005
ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
K043554 · IYN
B & K Medical A/S
Radiology · 18d
Cleared Jan 13, 2005
PALOMAR STARLUX PULSED LIGHT SYSTEM
K041086 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 262d
Cleared Jan 13, 2005
SAN-MAR LABS LUBRICATING JELLY
K041667 · HIS
San-Mar Laboratories, Inc.
Obstetrics & Gynecology · 209d
Cleared Jan 13, 2005
POWERSTICK MALE LATEX CONDOMS
K041717 · HIS
A.P.Deauville, LLC
Obstetrics & Gynecology · 203d
Cleared Jan 13, 2005
PFA PATCH
K041736 · DXZ
Peritec Biosciences, LLC
Cardiovascular · 199d
Cleared Jan 13, 2005
PALOMAR LUX1064 HANDPIECE
K041879 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 185d
Cleared Jan 13, 2005
PMP4 SELFCHECK ECG
K042254 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d