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
56089–56112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G,...
K081229 · JKA
Smiths Medical Asd, Inc.
Chemistry · 82d
Cleared Jul 21, 2008
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081249 · DEB
Dade Behring, Inc.
Immunology · 80d
Cleared Jul 21, 2008
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
K081515 · FOS
Neomed, Inc.
General Hospital · 52d
Cleared Jul 21, 2008
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
K081655 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 39d
Cleared Jul 18, 2008
SIALO DRAIN
K072334 · OAJ
Sialo Technology, Ltd.
Dental · 333d
Cleared Jul 18, 2008
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
K080067 · MPA
Iscience Interventional
Ophthalmic · 190d
Cleared Jul 18, 2008
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601,...
K080125 · LBS
Wako Chemicals USA, Inc.
Chemistry · 183d
Cleared Jul 18, 2008
WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
K080465 · ILY
Ws Far IR Medical Technology Co., Ltd.
Physical Medicine · 148d
Cleared Jul 18, 2008
MODIFIED HD GUIDE CATHETER
K080583 · DQY
Concentric Medical, Inc.
Cardiovascular · 137d
Cleared Jul 18, 2008
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · FJK
Nxstage Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · HAW
Smith & Nephew, Inc.
Neurology · 109d
Cleared Jul 18, 2008
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK...
K081061 · FLL
Harvard Medical Devices , Ltd.
General Hospital · 95d
Cleared Jul 18, 2008
CADD MEDICATION CASSETTE RESERVOIR
K081156 · FPA
Smiths Medical MD, Inc.
General Hospital · 86d
Cleared Jul 18, 2008
CINCH ANCHOR, MODEL 1194
K081208 · GZB
Advanced Neuromodulation Systems
Neurology · 80d
Cleared Jul 18, 2008
VARIAX DISTAL FIBULA PLATE
K081284 · KTT
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jul 18, 2008
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · PNG
C.R. Bard, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 18, 2008
SIMPLANT ORTHO
K081402 · LLZ
Materialise Dental NV
Radiology · 60d
Cleared Jul 18, 2008
SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM
K081452 · HSB
Synthes (Usa)
Orthopedic · 56d
Cleared Jul 18, 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · LLZ
Medtronic Navigation, Inc.
Radiology · 49d
Cleared Jul 18, 2008
MERETE 3.0 AND 3.5 MM LOCKING SCREWS
K081513 · HWC
Merete Medical GmbH
Orthopedic · 49d
Cleared Jul 18, 2008
AOC SOLUBLE IMPLANT MATERIAL
K081531 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 46d
Cleared Jul 18, 2008
CHROMOLITE EP
K081619 · GEX
Chromogenex Technologies Limited
General & Plastic Surgery · 39d
Cleared Jul 18, 2008
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
K081631 · MNH
Sintea Biotech, Inc.
Orthopedic · 37d
Cleared Jul 18, 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719 · GKR
Stanbio Laboratory
Hematology · 30d