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
48361–48384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2011
ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K102238 · MSD
Teleflexmedical, Inc.
Gastroenterology & Urology · 176d
Cleared Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
K103056 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 109d
Cleared Jan 31, 2011
PICCOLO COMPOSITE NAILING SYSTEM
K102369 · HSB
N.M.B. Medical Applications, Ltd.
Orthopedic · 164d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · KWS
Tornier, Inc.
Orthopedic · 123d
Cleared Jan 31, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · PHX
Encore Medical, L.P.
Orthopedic · 91d
Cleared Jan 31, 2011
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION...
K103254 · KNT
Coloplast A/S
Gastroenterology & Urology · 89d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · LPH
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 31, 2011
DEKA SYNCHRO FT
K103288 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 84d
Cleared Jan 31, 2011
SYNAPSE 3D CARDIAC TOOLS
K103465 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 68d
Cleared Jan 31, 2011
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K103677 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 46d
Cleared Jan 31, 2011
COR ANALYZER
K110071 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 21d
Cleared Jan 28, 2011
ANS SYSTEM
K101016 · DPS
Caird Technology
Cardiovascular · 291d
Cleared Jan 28, 2011
FISIO CHAMBER SPACE
K101136 · NVP
Koo (Shanghai) Industries Co., Ltd.
Anesthesiology · 281d
Cleared Jan 28, 2011
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER...
K101263 · KWT
Lima-Lto S.P.A.
Orthopedic · 268d
Cleared Jan 28, 2011
MAMMAPRINT
K101454 · NYI
Agendia
Pathology · 248d
Cleared Jan 28, 2011
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
K102319 · IRP
Won Industrial Co.
Physical Medicine · 164d
Cleared Jan 28, 2011
SOLSTICE
K102621 · EBZ
Kerr Corporation
Dental · 137d
Cleared Jan 28, 2011
HEMA SCREEN ER
K102664 · KHE
Immunostics Inc.,
Hematology · 135d
Cleared Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K102824 · BTM
Ambu A/S
Anesthesiology · 121d
Cleared Jan 28, 2011
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
K102884 · FRC
Advanced Sterilization Products
General Hospital · 120d
Cleared Jan 28, 2011
SENTICARE PILLSTATION
K103009 · NXQ
Senticare, Inc.
General Hospital · 108d
Cleared CT Jan 28, 2011
MIRADRY SYSTEM
K103014 · OUB
Miramar Labs, Inc.
General & Plastic Surgery · 107d
Cleared Jan 28, 2011
NEUCOLONCARE
K110077 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 17d
Cleared Jan 27, 2011
FLUID FILLED TEETHER - GEL
K092025 · KKO
Kids II
Dental · 570d