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
57793–57816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2007
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · DQK
St Jude Medical
Cardiovascular · 170d
Cleared Dec 20, 2007
ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
K071885 · OED
Philips Medical Systems
Cardiovascular · 164d
Cleared Dec 20, 2007
BELMONT QUOLIS 5000 SERIES DENTAL UNIT
K072273 · NRD
Takara Belmont USA, Inc.
Dental · 127d
Cleared Dec 20, 2007
CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)
K072518 · LJS
Crs Medical Diagnostics, Inc.
General Hospital · 104d
Cleared Dec 20, 2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S)...
K072599 · NOE
Diadexus, Inc.
Chemistry · 97d
Cleared Dec 20, 2007
MALIBU SPINAL SYSTEM
K072605 · NKB
Seaspine, Inc.
Orthopedic · 94d
Cleared Dec 20, 2007
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
K072631 · NHT
Idaho Technology, Inc.
Microbiology · 93d
Cleared Dec 20, 2007
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
K072642 · NHA
Biomet 3i, Inc.
Dental · 93d
Cleared Dec 20, 2007
3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
K072697 · DTN
3t Medical Systems, LLC
Cardiovascular · 87d
Cleared Dec 20, 2007
KLS MARTIN XTERNAL FIXATOR
K072764 · MQN
KLS-Martin L.P.
Dental · 83d
Cleared Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · HGM
Ge Healthcare
Obstetrics & Gynecology · 56d
Cleared Dec 20, 2007
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
K072980 · DZE
Nobel Biocare AB
Dental · 58d
Cleared Dec 20, 2007
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
K073127 · FMI
Shandong Weigao Group Medical Polymer...
General Hospital · 44d
Cleared Dec 20, 2007
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · HSX
Smith & Nephew, Inc.
Orthopedic · 37d
Cleared Dec 20, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K073193 · LYZ
Shijiazhuang Prosperous Plastic Co.,...
General Hospital · 37d
Cleared Dec 20, 2007
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
K073230 · DTA
Biotronik, Inc.
Cardiovascular · 35d
Cleared Dec 20, 2007
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 30d
Cleared Dec 20, 2007
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE...
K073304 · FZP
Cardica, Inc.
General & Plastic Surgery · 27d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325 · MBH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Dec 20, 2007
MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
K073397 · DXN
Microlife Corp.
Cardiovascular · 17d
Cleared Dec 20, 2007
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
K073398 · DXN
Microlife Corp.
Cardiovascular · 17d
Cleared Dec 20, 2007
VARICATH PERIPHERAL INFUSION CATHETER
K073400 · KRA
Veinrx, Inc.
Cardiovascular · 16d
Cleared Dec 20, 2007
MEDICAL DISPLAY, MD205MG
K073448 · LLZ
Nec Display Solutions , Ltd.
Radiology · 10d
Cleared Dec 20, 2007
T-QUEST SYSTEM
K073456 · IYX
Medx, Inc.
Radiology · 10d