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
51769–51792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2009
BIODRIVE MICRO SCREW SYSTEM
K092670 · HRS
Ebi,Llc D/B/A Biomet Trauma
Orthopedic · 80d
Cleared Nov 19, 2009
ACUTE AND CHRONIC CATHETER REPAIR KIT
K092797 · NFK
Kendall
Gastroenterology & Urology · 69d
Cleared Nov 19, 2009
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518...
K093399 · KNW
Inrad
Gastroenterology & Urology · 17d
Cleared CT Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
K083757 · LYL
Bausch & Lomb, Inc.
Ophthalmic · 336d
Cleared Nov 18, 2009
NEWPORT HT70 FAMILY OF VENTILATORS
K090888 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 232d
Cleared Nov 18, 2009
STERILE WATER FOR INHALATION FLEX BAG, USP
K090915 · BTT
Cardinal Health, Inc.
Anesthesiology · 231d
Cleared Nov 18, 2009
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714 · DJZ
Skyfine Inc. Limited
Toxicology · 161d
Cleared Nov 18, 2009
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
K091874 · ETN
Inomed Medizintechnik GmbH
Ear, Nose, Throat · 148d
Cleared Nov 18, 2009
VPS CATHETER
K091924 · LJS
Vasonova, Inc.
General Hospital · 141d
Cleared Nov 18, 2009
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840,...
K092040 · LJS
R4 Vascular, Inc.
General Hospital · 139d
Cleared Nov 17, 2009
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
K080459 · LAS
Chromsystems Instruments & Chemicals...
Toxicology · 636d
Cleared Nov 17, 2009
PIONEER SURGICAL NANOSS BVF-E
K091031 · MQV
Pioneer Surgical Technology
Orthopedic · 221d
Cleared Nov 17, 2009
GLUCO LAB AUTO CODING, MODEL IGM-0022
K091157 · NBW
Infopia Co, Ltd.
Chemistry · 210d
Cleared Nov 17, 2009
INTREPID SPINAL SYSTEM
K091813 · OVD
Medtronic Sofamor Danek
Orthopedic · 152d
Cleared Nov 17, 2009
METASUL TAPER LINERS, METASUL FEMORAL HEADS
K091973 · KWA
Zimmer GmbH
Orthopedic · 139d
Cleared Nov 17, 2009
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
K092239 · HAW
Medtech S.A
Neurology · 117d
Cleared Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271 · IYN
Ge Healthcare
Radiology · 112d
Cleared Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K092374 · HKI
Ophthalmic Imaging Systems
Ophthalmic · 104d
Cleared Nov 17, 2009
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401 · LYA
Sinexus, Inc.
Ear, Nose, Throat · 103d
Cleared Nov 17, 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556 · HRS
Synthes (Usa)
Orthopedic · 89d
Cleared Nov 17, 2009
SPARTAN S3 FACET SYSTEM
K092568 · MRW
Amendia, Inc.
Orthopedic · 89d
Cleared Nov 17, 2009
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES...
K092609 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 17, 2009
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
K092659 · KWQ
Spinal USA
Orthopedic · 81d
Cleared Nov 17, 2009
EASYRA MG REAGENT, MODEL 10220
K092737 · JGJ
Medica Corp.
Chemistry · 70d