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

Filters: Cleared only ×
176,076 results
56473–56496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2008
FALCK APPLANATION TONOMETER (FAT2)
K071755 · HKY
Falck Medical, Inc.
Ophthalmic · 341d
Cleared Jun 03, 2008
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
K073708 · KWQ
Precision Surgery , Ltd.
Orthopedic · 155d
Cleared Jun 03, 2008
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
K080555 · ITX
Ivu Imaging Corporation
Radiology · 96d
Cleared Jun 03, 2008
BONEMEDIK-DM
K080772 · LYC
Meta Biomed Co., Ltd.
Dental · 76d
Cleared Jun 03, 2008
REJUVENATE MODULAR HIP SYSTEM
K081044 · MEH
Howmedica Osteonics Corp.
Orthopedic · 50d
Cleared Jun 03, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K081097 · HTY
Orthopediatrics, LLC
Orthopedic · 47d
Cleared Jun 03, 2008
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
K081449 · MMK
Ultimed, Inc.
General Hospital · 11d
Cleared Jun 02, 2008
METHA HIP SYSTEM
K071916 · MEH
Aesculap Implant Systems, Inc.
Orthopedic · 327d
Cleared Jun 02, 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION...
K072080 · LGZ
Smiths Medical Asd, Inc.
General Hospital · 308d
Cleared Jun 02, 2008
ACCIN UNIPOLAR HEAD SYSTEM
K080539 · JDI
Accelerated Innovation, LLC
Orthopedic · 96d
Cleared Jun 02, 2008
BTI FILTRATION DEIONIZATION EXCHANGE TANK
K080703 · FIP
4m Ventures, Inc.
Gastroenterology & Urology · 82d
Cleared Jun 02, 2008
CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3
K080973 · JJY
Cliniqa Corporation
Chemistry · 59d
Cleared Jun 02, 2008
SOMATOM DEFINITION, MODEL AS/AS+
K081022 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 30, 2008
BARD E LUMINEXX BILIARY STENT
K063532 · FGE
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 555d
Cleared May 30, 2008
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
K063723 · KFM
Abiomed, Inc.
Cardiovascular · 532d
Cleared May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · MXJ
Zeus Scientific, Inc.
Microbiology · 298d
Cleared May 30, 2008
PROVOX MICRON HME
K072582 · JOH
Atos Medical AB
Anesthesiology · 260d
Cleared May 30, 2008
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K073051 · FRN
Medrad, Inc.
General Hospital · 214d
Cleared May 30, 2008
RAPID TOX CUP
K073078 · LAG
American Bio Medica Corp.
Toxicology · 212d
Cleared May 30, 2008
IVENT 2001 MRI CONDITIONAL
K073694 · CBK
Versamed Medical Systems, Inc.
Anesthesiology · 151d
Cleared May 30, 2008
MUCOGRAFT COLLAGEN MATRIX
K073711 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 151d
Cleared May 30, 2008
I-MINI DENTAL IMPLANT
K080115 · DZE
Oco Biomedical
Dental · 135d
Cleared May 30, 2008
SECURE IMPLANT SYSTEM (2.5/3.0MM)
K080129 · DZE
Dio Department Dsi, Inc.
Dental · 134d
Cleared May 30, 2008
TSO3 OZONE STERILIZATION WRAP
K080198 · FRG
Tso3, Inc.
General Hospital · 126d