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
61249–61272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2006
ECLIPSE TCD NEUROVASCULAR WORKSTATION
K061639 · GWF
Axon Systems, Inc.
Radiology · 142d
Cleared Nov 01, 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · CIG
Nova Biomedical Corp.
Chemistry · 126d
Cleared Nov 01, 2006
KOWA VX-10I
K062021 · HKI
Kowa Co. , Ltd.
Ophthalmic · 107d
Cleared Nov 01, 2006
SS SYSTEM
K062051 · DZE
Osstem Implant Co., Ltd.
Dental · 105d
Cleared Nov 01, 2006
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER,...
K062323 · LZG
Smiths Medical MD, Inc.
General Hospital · 84d
Cleared Nov 01, 2006
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · HQD
Contamac, Ltd.
Ophthalmic · 63d
Cleared Nov 01, 2006
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED...
K062614 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 57d
Cleared Nov 01, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 42d
Cleared Nov 01, 2006
PRIMACONNEX CERAMIC ABUTMENTS
K062876 · NHA
Lifecore Biomedical, Inc.
Dental · 36d
Cleared Nov 01, 2006
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
K063033 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 29d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
K063099 · LRG
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 01, 2006
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
K063101 · LRG
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 31, 2006
MAGPRO, MODEL R30
K061645 · GWF
Tonica Elektronik A/S
Neurology · 141d
Cleared Oct 31, 2006
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
K061925 · HTN
Arthrex, Inc.
Orthopedic · 116d
Cleared Oct 31, 2006
CHRONOS VISION EYE TRACKING DEVICE (C-ETD)
K062015 · GWN
Chronos Vision
Neurology · 106d
Cleared Oct 31, 2006
ANATOMICAL SHOULDER FRACTURE SYSTEM
K062029 · KWS
Zimmer GmbH
Orthopedic · 105d
Cleared Oct 31, 2006
OXYLOG 3000
K062267 · CBK
Drager Medical B.V.
Anesthesiology · 88d
Cleared Oct 31, 2006
SMARTLIPO ND:YAG LASER
K062321 · GEX
Cynosure, Inc.
General & Plastic Surgery · 83d
Cleared Oct 31, 2006
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
K062472 · IZL
Source-Ray, Inc.
Radiology · 68d
Cleared Oct 31, 2006
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
K062476 · JFB
Ceragem International, Inc.
Physical Medicine · 68d
Cleared Oct 31, 2006
PATIENT CONTOURED MESH (PCM)
K062570 · GXN
KLS-Martin L.P.
Neurology · 61d
Cleared Oct 31, 2006
IMT.LAB SOFTWARE
K062598 · LLZ
Esaote Europe B.V.
Radiology · 60d
Cleared Oct 31, 2006
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
K062743 · LLZ
Electronic Business Machine Co., Ltd....
Radiology · 47d
Cleared Oct 31, 2006
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
K062861 · HSD
Ascension Orthopedics, Inc.
Orthopedic · 36d