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
51457–51480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2009
ONTEX TAMPON (UNSCENTED)
K090819 · HEB
Ontex International NV
Obstetrics & Gynecology · 273d
Cleared Dec 23, 2009
TRIA HAIR REMOVAL LASER SYSTEM
K090820 · GEX
Spectragenics, Inc.
General & Plastic Surgery · 272d
Cleared Dec 23, 2009
RAPID-I
K090832 · MQK
Vitrolife Sweden AB
Obstetrics & Gynecology · 272d
Cleared Dec 23, 2009
ZOLL E SERIES WITH CPRREADYCHARGE
K091265 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 237d
Cleared Dec 23, 2009
CERVICORE CORPECTOMY CAGE
K091426 · MQP
Verticor, Ltd.
Orthopedic · 224d
Cleared CT Dec 23, 2009
FORESEE HOME
K091579 · HPT
Notal Vision , Ltd.
Ophthalmic · 204d
Cleared Dec 23, 2009
SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
K091644 · HRS
Synthes (Usa)
Orthopedic · 202d
Cleared Dec 23, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729 · LYC
Etex Corp.
Dental · 195d
Cleared Dec 23, 2009
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND...
K091749 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 190d
Cleared Dec 23, 2009
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · GZB
Advanced Neuromodulation Systems
Neurology · 140d
Cleared Dec 23, 2009
ZIEHM SOLO
K092438 · OWB
Ziehm Imaging, Inc.
Radiology · 138d
Cleared Dec 23, 2009
O-SCAN MR SYSTEM
K092469 · LNH
Esaote, S.P.A.
Radiology · 134d
Cleared CT Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905,...
K092510 · DXN
Andon Health Co, Ltd.
Cardiovascular · 128d
Cleared Dec 23, 2009
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
K092803 · JWH
Cardo Medical Corp.
Orthopedic · 103d
Cleared Dec 23, 2009
OTI-SCAN 3000
K092837 · IYO
Opko Instrumentation, Inc.
Radiology · 99d
Cleared Dec 23, 2009
CONMED LINVATEC INTERCEPT IMPLANT
K092998 · MBI
Linvatec Corp.
Orthopedic · 86d
Cleared Dec 23, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · MNI
Alphatec Spine, Inc.
Orthopedic · 84d
Cleared Dec 23, 2009
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
K093098 · KQO
Arkray, Inc.
Chemistry · 83d
Cleared Dec 23, 2009
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · MAX
Globus Medical, Inc.
Orthopedic · 69d
Cleared Dec 23, 2009
SIMUPLAN TREATMENT PLANNING SYSTEM
K093391 · MUJ
Simuplan S.L.
Radiology · 54d
Cleared Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415 · GQS
Diagnostic Hybrids, Inc.
Microbiology · 51d
Cleared Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
K093452 · DXN
Andon Health Co, Ltd.
Cardiovascular · 48d
Cleared Dec 23, 2009
VASCUVIEW TAP ULTRASOUND SYSTEM
K093613 · IYN
Escalon Medical Corp.
Radiology · 30d
Cleared Dec 23, 2009
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
K093616 · OCV
Carefusion 2200
Gastroenterology & Urology · 34d