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
53713–53736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · LOJ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Apr 27, 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
K090822 · DQY
Cook, Inc.
Cardiovascular · 32d
Cleared Apr 27, 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · LHI
B.Braun Medical, Inc.
General Hospital · 26d
Cleared Apr 24, 2009
SKLAR SURGICAL GOWN
K082479 · FYA
Sklar Corp.
General Hospital · 239d
Cleared Apr 24, 2009
NOVAGUARD, MODEL 3611001
K082908 · FMI
West Pharmaceutical Services, Inc.
General Hospital · 206d
Cleared Apr 24, 2009
PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND...
K083351 · DQA
Comdek Industrial Corp.
Anesthesiology · 162d
Cleared Apr 24, 2009
LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
K083509 · MQL
Intl., Inc.
Obstetrics & Gynecology · 149d
Cleared Apr 24, 2009
MOBILECARE MONITOR, MODEL 2100
K090138 · KMI
Aframe Digital, Inc.
General Hospital · 93d
Cleared Apr 24, 2009
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL...
K090178 · KPS
Neusoft Positron Medical Systems Co.,...
Radiology · 88d
Cleared Apr 24, 2009
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
K090185 · NBW
Taidoc Technology Corporation
Chemistry · 88d
Cleared Apr 24, 2009
BILI BLUE F20T12/BBY AND F40T12/BBY
K090192 · LBI
Interlectric Corp.
General Hospital · 87d
Cleared Apr 24, 2009
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
K090299 · LZO
Aesculap Implant Systems
Orthopedic · 77d
Cleared Apr 24, 2009
PEDIPLATES
K090666 · HRS
OrthoPediatrics Corp.
Orthopedic · 42d
Cleared Apr 24, 2009
STRYKER SPINE AVS PL PEEK SPACERS
K090816 · MAX
Stryker Corp.
Orthopedic · 30d
Cleared Apr 24, 2009
MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
K090839 · HRS
Syntec Scientific Corp.
Orthopedic · 28d
Cleared Apr 23, 2009
WALGREEN'S PERSONAL LUBRICATING JELLY
K080978 · NUC
Topco Sales
Obstetrics & Gynecology · 381d
Cleared Apr 23, 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
K082934 · HWC
Extremity Medical, LLC
Orthopedic · 204d
Cleared Apr 23, 2009
REBOUND HRDV
K083467 · FTL
Minnesota Medical Development, Inc.
General & Plastic Surgery · 150d
Cleared Apr 23, 2009
CLUE MEDICAL AND CLUE MEDICAL BASIC
K083630 · DXH
Telovital GmbH Telemedizin
Cardiovascular · 136d
Cleared Apr 23, 2009
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
K083889 · GEX
Fotona D.D.
General & Plastic Surgery · 115d
Cleared Apr 23, 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053 · HRS
Medartis AG
Orthopedic · 105d
Cleared Apr 23, 2009
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · FBK
Coloplast A/S
Gastroenterology & Urology · 84d
Cleared Apr 23, 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
K090464 · LZA
Pt Mahakarya Inti Buana
General Hospital · 59d
Cleared Apr 23, 2009
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
K090695 · HBL
Dinkler Surgical Devices, Inc.
Neurology · 38d