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
52897–52920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2009
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59,...
K090613 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 117d
Cleared Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · LGD
Bio-Rad Laboratories
Microbiology · 93d
Cleared Jul 01, 2009
MINIME PEDIATRIC MASK
K090935 · BZD
Sleepnet Corporation
Anesthesiology · 90d
Cleared Jul 01, 2009
APTUS 2.0/2.3 FOUR CORNER FUSION PLATE
K090983 · HRS
Medartis AG
Orthopedic · 85d
Cleared Jul 01, 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
K091299 · DQY
Spectranetics Corp.
Cardiovascular · 58d
Cleared Jul 01, 2009
MERCURY SPINAL SYSTEM
K091587 · NKB
Spinal Elements, Inc.
Orthopedic · 29d
Cleared Jul 01, 2009
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670 · LJS
Becton, Dickinson & CO
General Hospital · 22d
Cleared Jul 01, 2009
FLAATZ 500
K091747 · KPR
Drtech Corp.
Radiology · 15d
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 13d
Cleared Jul 01, 2009
THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
K091855 · FRN
Belmont Instrument Corp.
General Hospital · 8d
Cleared Jul 01, 2009
PINNACLE STAIR WAY LIFT
K091858 · ILK
Summit Harmar, LLC
Physical Medicine · 8d
Cleared Jul 01, 2009
RPL/CPL VERTICAL PLATFORM LIFTS
K091881 · ING
Harmar Summit, LLC
Physical Medicine · 7d
Cleared Jun 30, 2009
IDR
K082450 · MQB
Icrco, Inc.
Radiology · 309d
Cleared Jun 30, 2009
XPRESSE INJECTION SYSTEM
K083583 · FMF
Nordson Efd
General Hospital · 208d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115 · HKI
Topcon Corp.
Ophthalmic · 160d
Cleared Jun 30, 2009
SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
K090268 · IZL
Shimadzu Corp.
Radiology · 147d
Cleared Jun 30, 2009
CONTRA-ANGLE HANDPIECE KOMET OS30
K090548 · EFB
W&H Dentalwerk Buermoos GmbH
Dental · 120d
Cleared Jun 30, 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565 · KWP
Globus Medical, Inc.
Orthopedic · 120d
Cleared Jun 30, 2009
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS...
K090596 · HSB
Zimmer, Inc.
Orthopedic · 117d
Cleared Jun 30, 2009
REGIONAL OXIMETER SYSTEM, MODEL 7600
K090807 · MUD
Nonin Medical, Inc.
Cardiovascular · 97d
Cleared Jun 30, 2009
HANSO ACUPUNCTURE NEEDLE
K090910 · MQX
Hansol Medical Co.
General Hospital · 90d
Cleared Jun 30, 2009
PARCUS GRAFT FIXATION SYSTEM
K090923 · MBI
Parcus Medical, LLC
Orthopedic · 90d
Cleared Jun 30, 2009
INERTIA PEDICLE SCREW SYSTEM
K090984 · MNI
Nexxt Spine, LLC
Orthopedic · 84d
Cleared Jun 30, 2009
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
K091391 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 50d