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
79657–79680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 2001
H-SCRIBE
K004017 · MLO
Mortara Instrument, Inc.
Cardiovascular · 166d
Cleared Jun 11, 2001
IMMUNOWELL EA (D) IGG TEST
K010301 · LSE
Genbio
Microbiology · 130d
Cleared Jun 11, 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT...
K010634 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 101d
Cleared Jun 11, 2001
BPFONE, MODEL UA 767IT
K010751 · DXN
Medical Monitors Pty Limited
Cardiovascular · 90d
Cleared Jun 11, 2001
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY
K010752 · KNF
Aesculap, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 11, 2001
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
K010760 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 11, 2001
ISLAND WOUND DRESSING WITH MICROBAN
K010951 · FRO
Island Dressing, LLC
General & Plastic Surgery · 75d
Cleared Jun 11, 2001
RESIN CEM
K011431 · EMA
S & C Polymer GmbH
Dental · 33d
Cleared Jun 08, 2001
SIGMA DELTA
K002343 · CAD
Penlon , Ltd.
Anesthesiology · 311d
Cleared Jun 08, 2001
ORIGEN DUAL LUMEN CATHETER
K003288 · DQO
Origen Biomedical, Inc.
Cardiovascular · 231d
Cleared Jun 08, 2001
MAR COR SERVICES BICARB SYSTEM
K003560 · FIN
Mar Cor Services, Inc.
Gastroenterology & Urology · 203d
Cleared Jun 08, 2001
BREAST-BOARD (MULTIPLE)
K003778 · IYE
Arplay Medical S.A.
Radiology · 183d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · DXN
Welch Allyn, Inc.
Cardiovascular · 137d
Cleared Jun 08, 2001
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
K010791 · DXH
Adsis , Ltd.
Cardiovascular · 85d
Cleared Jun 08, 2001
CARDIAC VIEW, MODEL 2001
K010802 · MOS
Magna-Lab, Inc.
Radiology · 84d
Cleared Jun 08, 2001
INSULIN PEN NEEDLE ADAPTER
K010887 · FMI
Ohana Needle Co.
General Hospital · 74d
Cleared Jun 08, 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966 · DQA
Alaris Medical Systems, Inc.
Anesthesiology · 67d
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · CAH
Allegiance Healthcare Corp.
General Hospital · 56d
Cleared Jun 08, 2001
ONE-STEP PLUS
K011159 · EMA
Bisco, Inc.
Dental · 58d
Cleared Jun 08, 2001
ULTRASOUND SCANNER, TYPE 2102
K011417 · IYO
B & K Medical A/S
Radiology · 30d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · LDP
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL...
K011494 · JJY
Bio-Rad
Immunology · 24d
Cleared Jun 08, 2001
INFANT FLOW SYSTEM, MODEL M672P
K011516 · BZD
Eme (Electro Medical Equipment) , Ltd.
Anesthesiology · 22d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · LFG
Medtox Diagnostics, Inc.
Toxicology · 21d