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
50977–51000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2010
REFINE SUPPORT SYSTEM, MODEL 100.0100
K092538 · FTL
Alure Medical, Inc.
General & Plastic Surgery · 198d
Cleared Mar 05, 2010
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE...
K092740 · CGN
Abbott Laboratories
Chemistry · 178d
Cleared Mar 05, 2010
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY...
K092907 · IYN
Shantou Institute of Ultrasonic...
Radiology · 164d
Cleared Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · GJS
Roche Diagnostics Corp.
Hematology · 162d
Cleared Mar 05, 2010
EMPI CONTINUUM
K093324 · IPF
Empi
Physical Medicine · 133d
Cleared Mar 05, 2010
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
K093336 · LNH
Medical Numerics, Inc.
Radiology · 130d
Cleared Mar 05, 2010
MIZZY EXPRESS
K093380 · EBG
Mycone Dental Supply Co., Inc.
Dental · 127d
Cleared Mar 05, 2010
CUATTRO UNOMD
K093480 · LLZ
Cuattro, LLC
Radiology · 116d
Cleared Mar 05, 2010
GLUMA DESENSITIZER POWER GEL
K093575 · LBH
Heraeus Kulzer, LLC
Dental · 107d
Cleared Mar 05, 2010
OPTISCAN MODEL OPTISCAN CEIS
K093624 · GCJ
Optiscan Pty. , Ltd.
General & Plastic Surgery · 102d
Cleared Mar 05, 2010
EXL ANEM CAL, MODEL RC640
K093645 · JIX
Siemens Healthcare Diagnostics
Chemistry · 100d
Cleared Mar 05, 2010
STRYKER ARTHROSCOPE
K093677 · HRX
Stryker Endoscopy
Orthopedic · 98d
Cleared Mar 05, 2010
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
K093761 · HRS
Biomet Trauma (Aka Ebi, Lp)
Orthopedic · 88d
Cleared Mar 05, 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K093842 · MOS
Invivo Corporation
Radiology · 80d
Cleared Mar 05, 2010
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093943 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 73d
Cleared Mar 05, 2010
ACUITY BREAK-AWAY GUIDE CATHETER
K093969 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 72d
Cleared Mar 05, 2010
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
K094017 · JWH
Omni Life Science, Inc.
Orthopedic · 66d
Cleared Mar 05, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100058 · LYZ
Tangshan Zhongpu Plastic Products...
General Hospital · 56d
Cleared Mar 05, 2010
CLEARFIL MAJETY POSTERIOR
K100328 · EBF
Kuraray Medical, Inc.
Dental · 29d
Cleared Mar 05, 2010
SITE-RITE VISION ULTRASOUND SYSTEM
K100402 · IYN
Bard Access Systems, Inc.
Radiology · 17d
Cleared Mar 05, 2010
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
K100446 · JOW
Devon Medical, Inc.
Cardiovascular · 16d
Cleared Mar 04, 2010
AESCULAP HYDROLIFT VBR SYSTEM
K083186 · MQP
Aesculap Implant System, Inc.
Orthopedic · 491d
Cleared CT Mar 04, 2010
VRLXP, MODEL XP
K091732 · OCR
Deep Breeze , Ltd.
Anesthesiology · 266d
Cleared Mar 04, 2010
HAMILTON-C2
K092148 · CBK
Hamilton Medical AG
Anesthesiology · 232d