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
67273–67296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2004
PROMEDICAL SURGICAL DRAPES
K042131 · KKX
Promedical Products Co., Ltd.
General Hospital · 123d
Cleared Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · DGC
Kamiya Biomedical Co.
Immunology · 113d
Cleared Dec 10, 2004
UNICRYL M
K042285 · NEW
United Medical Industries Co. , Ltd.
General & Plastic Surgery · 108d
Cleared Dec 10, 2004
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
K042461 · LJS
Kendall
General Hospital · 91d
Cleared Dec 10, 2004
IR VIEWER
K042679 · KZA
Infrared Imaging Systems, Inc.
General Hospital · 72d
Cleared Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
K042687 · MIF
Dade Behring, Inc.
Hematology · 72d
Cleared Dec 10, 2004
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784 · DXT
Medrad, Inc.
Cardiovascular · 65d
Cleared Dec 10, 2004
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873 · LZG
Animas Corp.
General Hospital · 53d
Cleared Dec 10, 2004
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114 · KNT
Kimberly-Clark Corp.
Gastroenterology & Urology · 30d
Cleared Dec 10, 2004
PANALIGHT-BLU, MODEL 4175
K043164 · GEX
Dusa Pharmaceuticals, Inc.
General & Plastic Surgery · 24d
Cleared Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227 · HRS
Zimmer, Inc.
Orthopedic · 18d
Cleared Dec 10, 2004
PALMSCAN AP2000
K043287 · IYO
Micromedical Devices, Inc.
Radiology · 11d
Cleared Dec 10, 2004
BLUE ORTHOCORD SUTURE
K043298 · NEW
Depuy Mitek
General & Plastic Surgery · 10d
Cleared Dec 10, 2004
MEDLEY PCA MODULE, MODEL 8120
K043299 · MEA
Alaris Medical Systems, Inc.
General Hospital · 10d
Cleared Dec 09, 2004
PATHFINDER
K041477 · HAW
Armstrong Healthcare Limited
Neurology · 189d
Cleared Dec 09, 2004
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
K042318 · JJY
Aalto Scientific, Ltd.
Chemistry · 105d
Cleared Dec 09, 2004
ACS MODEL NCP-2
K042413 · DRN
Applied Cardiac Systems
Cardiovascular · 93d
Cleared Dec 09, 2004
STRYKER CASSETTE PUMP
K042454 · GCX
Stryker Endoscopy
General Hospital · 90d
Cleared Dec 09, 2004
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
K042588 · FMF
Confluent Surgical,Inc
General Hospital · 78d
Cleared Dec 09, 2004
NICHOLS ADVANTAGE CORTISOL
K042689 · CGR
Nichols Institute Diagnostics
Chemistry · 71d
Cleared Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
K042838 · JIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 56d
Cleared Dec 09, 2004
MAGNETOM C! MR SYSTEM
K043030 · LNH
Siemens Medical Solutions
Radiology · 36d
Cleared Dec 09, 2004
AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)
K043041 · HCH
Aesculap, Inc.
Neurology · 35d
Cleared Dec 09, 2004
LIQUID STABLE HBA1C CONTROL
K043070 · JJX
Canterbury Scientific , Ltd.
Chemistry · 31d