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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48169–48192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2011
VTS1000
K101838 · KZA
Vuetek Scientific, LLC
General Hospital · 232d
Cleared Feb 18, 2011
LIQUIBAND DUAL, MODEL LBD 001
K102076 · MPN
Medlogic Global Limited
General & Plastic Surgery · 207d
Cleared Feb 18, 2011
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
K102206 · DPS
Mortara Instrument, Inc.
Cardiovascular · 197d
Cleared Feb 18, 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259 · JAK
VATECH Co., Ltd.
Radiology · 192d
Cleared Feb 18, 2011
X2ABS DUAL CHANNEL FITNESS BELT
K102295 · NGX
Leto Enterprises Incorporation
Physical Medicine · 189d
Cleared Feb 18, 2011
REPROCESSED PULSE OXIMETER SENSORS
K102560 · NLF
Sterilmed, Inc.
Anesthesiology · 164d
Cleared Feb 18, 2011
EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
K102776 · EBG
Deltamed GmbH
Dental · 147d
Cleared Feb 18, 2011
PATIENT EXAMINATION GLOES
K102840 · LYY
Thai Hua Holding Co., Ltd.
General Hospital · 142d
Cleared Feb 18, 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO...
K102961 · JXG
Codman & Shurtleff, Inc.
Neurology · 136d
Cleared Feb 18, 2011
INFINITY CNAP SMARTPOD
K102968 · DXN
Draeger Medical Systems, Inc.
Cardiovascular · 135d
Cleared Feb 18, 2011
STERILIZATION MATS
K103226 · KCT
STERIS Corporation
General Hospital · 109d
Cleared CT Feb 18, 2011
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
K103255 · OBJ
Vasonova, Inc.
Cardiovascular · 107d
Cleared CT Feb 18, 2011
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
K103260 · OBJ
Vasonova, Inc.
Cardiovascular · 106d
Cleared Feb 18, 2011
STEMPRO MSC SFM
K103302 · NDS
Life Technologies Corporation
Gastroenterology & Urology · 101d
Cleared Feb 18, 2011
SYNTHES SCOUT VESSEL GUARD
K103558 · OMR
Synthes Spine
Cardiovascular · 78d
Cleared Feb 18, 2011
MIM 5.2 (BRACHY)
K103576 · LLZ
Mim Software, Inc.
Radiology · 74d
Cleared Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
K103701 · JIX
Siemens Healthcare Diagnostics, Inc.
Immunology · 60d
Cleared Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Feb 18, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · DXN
Andon Health Co, Ltd.
Cardiovascular · 15d
Cleared Feb 17, 2011
MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
K093610 · NRY
Concentric Medical, Inc.
Neurology · 454d
Cleared Feb 17, 2011
TECO DIAGNOSTICS UTI DETECTION STRIPS
K100024 · JMT
Teco Diagnostics
Chemistry · 408d
Cleared Feb 17, 2011
FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR
K101510 · OUH
Endymed Medical, Ltd.
General & Plastic Surgery · 261d
Cleared Feb 17, 2011
NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM,...
K101893 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 225d
Cleared Feb 17, 2011
CLARITY ADVANCED CERAMIC BRACKETS
K102803 · NJM
3M Unitek Corporation
Dental · 142d