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
60145–60168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2007
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT
K070489 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 22d
Cleared Mar 14, 2007
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · KLE
Dentsply Intl.
Dental · 16d
Cleared Mar 13, 2007
GENGIGEL MOUTHRINSE
K053342 · OLR
Ricerfarma Srl
General & Plastic Surgery · 467d
Cleared Mar 13, 2007
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452 · JLX
Neo-Genesis
Chemistry · 385d
Cleared Mar 13, 2007
RETRO-TECH DRESSING
K060832 · FRO
Retro-Tech, LLC
General & Plastic Surgery · 351d
Cleared Mar 13, 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
K062872 · JDS
Synthes (Usa)
Orthopedic · 168d
Cleared Mar 13, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · NDN
Medtronic Sofamor Danek
Orthopedic · 138d
Cleared Mar 13, 2007
ELLEX SLIT LAMP, MODEL 30XL
K063352 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 127d
Cleared Mar 13, 2007
TENDERFLOW PERIATRIC ARTERIAL CANNULA
K063618 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 98d
Cleared Mar 13, 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
K070223 · JJY
Aalto Scientific, Ltd.
Chemistry · 48d
Cleared Mar 13, 2007
LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
K070285 · KWQ
Life Spine
Orthopedic · 43d
Cleared Mar 13, 2007
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
K070421 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Mar 12, 2007
SATURN 3 LASER SYSTEM
K060764 · MRX
Research Instruments , Ltd.
Obstetrics & Gynecology · 356d
Cleared Mar 12, 2007
NIGHT GUARD
K061122 · MQC
Alpine Oral Care, LLC
Dental · 322d
Cleared Mar 12, 2007
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · NDY
Thermo Electron OY
Chemistry · 95d
Cleared Mar 12, 2007
AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
K063712 · OTP
C.R. Bard, Inc.
Obstetrics & Gynecology · 88d
Cleared Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
K070083 · MST
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Mar 12, 2007
GRADIA DIRECT X
K070190 · EBF
GC America, Inc.
Dental · 49d
Cleared Mar 12, 2007
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B)...
K070308 · LPL
X-Cel Contacts
Ophthalmic · 39d
Cleared Mar 09, 2007
EXPRESSWAY INTERMITTENT CATHETER
K061766 · EZD
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 260d
Cleared Mar 09, 2007
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
K062659 · HQP
Kirwan Surgical Products, Inc.
Ophthalmic · 183d
Cleared Mar 09, 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
K062875 · OCW
Endogastric Solutions, Inc.
Gastroenterology & Urology · 164d
Cleared Mar 09, 2007
REPEATER PUMP II TUBE SETS
K062909 · FPA
Baxa Corp.
General Hospital · 163d
Cleared Mar 09, 2007
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
K062994 · KWA
Biomet Manufacturing Corp
Orthopedic · 158d