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
62161–62184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2006
ERAD PACS
K061421 · LLZ
Erad, Inc.
Radiology · 64d
Cleared Jul 25, 2006
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
K061429 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Jul 25, 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441 · MNH
Ebi, L.P.
Orthopedic · 62d
Cleared Jul 25, 2006
SYNGO EXPERT-1
K061449 · JAK
Siemens Medical Solution
Radiology · 61d
Cleared Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
K061582 · JAQ
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 25, 2006
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
K061637 · IYN
Shimadzu Medical Systems
Radiology · 43d
Cleared Jul 25, 2006
HITCH LACTOSORB SUTURE ANCHOR
K061657 · JDR
Arthrotek, Inc.
Orthopedic · 42d
Cleared Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665 · HWC
Arthrex, Inc.
Orthopedic · 41d
Cleared Jul 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
K061724 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 36d
Cleared Jul 25, 2006
INTEGRA RADIONICS XKNIFE RT 4
K061893 · MUJ
Integra Radionics, Inc.
Radiology · 22d
Cleared Jul 25, 2006
CD HORIZON SPINAL SYSTEM
K061915 · MNH
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 25, 2006
21.3 INCH MONOCHROME LCD MONITOR
K061947 · LLZ
Nec Display Solutions , Ltd.
Radiology · 15d
Cleared Jul 25, 2006
SURGI-CUF REUSABLE, RS SERIES
K061962 · DXQ
Ethox International
Cardiovascular · 13d
Cleared Jul 24, 2006
OR SPECIFIC BIG CASE BACK TABLE COVER
K052668 · KKX
Or Specific, Inc.
General Hospital · 300d
Cleared Jul 24, 2006
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K053490 · CAF
Merits Health Products Co., Ltd.
Anesthesiology · 221d
Cleared Jul 24, 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
K061151 · MQP
Pioneer Surgical Technology
Orthopedic · 90d
Cleared Jul 24, 2006
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · KWQ
Blackstone Medical, Inc.
Orthopedic · 83d
Cleared Jul 24, 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786 · LPH
Zimmer, Inc.
Orthopedic · 28d
Cleared Jul 21, 2006
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
K051958 · DJG
Mp Biomedicals, LLC
Toxicology · 367d
Cleared Jul 21, 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
K053597 · NBC
I-Stat Corporation
Chemistry · 210d
Cleared Jul 21, 2006
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · CJE
Horiba Abx
Chemistry · 176d
Cleared Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · JOZ
Dade Behring, Inc.
Hematology · 147d
Cleared Jul 21, 2006
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619 · KHS
Diazyme Laboratories
Chemistry · 135d
Cleared Jul 21, 2006
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
K060739 · CBF
Khrunichev State Research &...
Anesthesiology · 123d