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

Filters: Cleared only ×
176,076 results
69097–69120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2004
REFOBACIN -PALACOS G
K031673 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 361d
Cleared May 25, 2004
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
K032914 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 246d
Cleared May 25, 2004
SIMPLEX X
K032945 · LOD
Stryker Corp.
Orthopedic · 246d
Cleared May 25, 2004
JMS BYPASS TUBE
K032977 · DWF
Jms North America Corp.
Cardiovascular · 244d
Cleared May 25, 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · HNO
Micro Specialties, Inc.
Ophthalmic · 208d
Cleared May 25, 2004
TRANSXCHANGE SUPPORT CATHETER
K033540 · DQY
Medtronic Vascular
Cardiovascular · 197d
Cleared May 25, 2004
SMARTLANK WIRELESS, MODEL 001970
K033642 · MKJ
Mrl, A Welch Allyn Company
Cardiovascular · 187d
Cleared May 25, 2004
SIMPLANT SYSTEM
K033849 · LLZ
Materialise NV
Radiology · 166d
Cleared May 25, 2004
TRIDENT T ACETABULAR SHELLS
K040412 · LPH
Stryker Orthopaedics
Orthopedic · 97d
Cleared May 25, 2004
ECONOLITH E3000, MODEL 3000 (SW-6)
K040461 · LNS
Medispec, Ltd.
Gastroenterology & Urology · 92d
Cleared May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 90d
Cleared May 25, 2004
ARTHROTEK LACTONAIL
K040500 · HTY
Arthrotek, Inc.
Orthopedic · 89d
Cleared May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared May 25, 2004
METACRYL
K040881 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 50d
Cleared May 25, 2004
TRIGEN ADOLESCENT TAN
K040929 · HSB
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared May 25, 2004
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
K040995 · KPR
Analogic Corp.
Radiology · 39d
Cleared May 25, 2004
MEDLINE STRIDER MICRO 3
K041053 · INI
Medline Industries, Inc.
Physical Medicine · 32d
Cleared May 25, 2004
MEDLINE STRIDER MAXI 3
K041054 · INI
Medline Industries, Inc.
Physical Medicine · 32d
Cleared May 25, 2004
MEDLINE STRIDER MAXI 4
K041055 · INI
Medline Industries, Inc.
Physical Medicine · 32d
Cleared May 25, 2004
HEARTSINE SAMARITAN PAD
K041067 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 32d
Cleared May 25, 2004
A&I SCOOTER, SC-301
K041187 · INI
Well Success Biotech, Inc.
Physical Medicine · 19d
Cleared May 25, 2004
A&I POWER WHEELCHAIR, PC-401
K041190 · ITI
Well Success Biotech, Inc.
Physical Medicine · 19d
Cleared May 25, 2004
A&I SCOOTER, SC-402
K041193 · INI
Well Success Biotech, Inc.
Physical Medicine · 19d
Cleared May 24, 2004
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
K040255 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 110d