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
67153–67176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2004
HEALTHSTAR ELITE
K043239 · ITH
Hill Laboratories Co.
Physical Medicine · 29d
Cleared Dec 22, 2004
DUCERA ALLCERAM
K043247 · EIH
Dentsply Intl.
Dental · 29d
Cleared Dec 22, 2004
Lysus Infusion System
K043269 · QEY
Ekos Corp.
Cardiovascular · 26d
Cleared Dec 22, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
K043272 · MSD
Kendall
Gastroenterology & Urology · 26d
Cleared Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · NBW
Bayer Healthcare, LLC
Chemistry · 21d
Cleared Dec 21, 2004
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
K033044 · ELC
American Green Dent. Mfg, Inc.
Dental · 449d
Cleared Dec 21, 2004
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487 · MBH
Implex Corp.
Orthopedic · 300d
Cleared Dec 21, 2004
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
K041038 · KPE
Churchill Medical Systems, Inc.
General Hospital · 243d
Cleared Dec 21, 2004
SERFAS ENERGY SYSTEM
K041810 · GEI
Stryker Endoscopy
General & Plastic Surgery · 168d
Cleared Dec 21, 2004
MEDALLION MODULAR HIP SYSTEM
K041850 · LPH
Biomet Manufacturing, Inc.
Orthopedic · 166d
Cleared Dec 21, 2004
APEX K2 HIP SYSTEM
K041950 · LPH
Apex Surgical, LLC
Orthopedic · 154d
Cleared Dec 21, 2004
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
K042000 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 148d
Cleared Dec 21, 2004
NOVASYS TRANSURETHRAL RF SYSTEM
K042132 · NVJ
Novasys Medical, Inc.
General & Plastic Surgery · 134d
Cleared Dec 21, 2004
LUTH-ALL SUB-Q NEEDLE SET
K042666 · FPA
Luth-All Medical Products, LLC
General Hospital · 83d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789 · KWP
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · JXG
Integra LifeSciences Corporation
Neurology · 70d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841 · JDL
Biomet, Inc.
Orthopedic · 68d
Cleared Dec 21, 2004
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3,...
K042871 · LPH
Zimmer Trabecular
Orthopedic · 64d
Cleared Dec 21, 2004
MODIFICATION TO: PLEXALONG SETS
K042979 · BSP
Pajunk GmbH
Anesthesiology · 53d
Cleared Dec 21, 2004
OLYMPUS ENDOARM
K043128 · GWG
Olympus Corporation
Neurology · 39d
Cleared Dec 21, 2004
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K043130 · CAZ
Pajunk GmbH
Anesthesiology · 39d
Cleared Dec 21, 2004
UNIVERSAL XACTTRACE
K043132 · MNR
Medcare Flaga
Anesthesiology · 39d
Cleared Dec 21, 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · KWP
Interpore Cross Intl.
Orthopedic · 29d
Cleared Dec 21, 2004
UCR SPINAL SYSTEM
K043232 · NKB
Seaspine
Orthopedic · 29d