FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
74257–74280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2002
ULTRAGUIDE CTG 2000SA
K022354 · JAK
Ultraguide , Ltd.
Radiology · 25d
Cleared Aug 13, 2002
HRH-127-8 HEAD ARRAY COIL
K022372 · MOS
Mri Devices Corp.
Radiology · 22d
Cleared Aug 13, 2002
1.5T SCANMED PV ARRAY
K022395 · MOS
Medic, Inc.
Radiology · 21d
Cleared Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · DXQ
Ge Medical Systems Information...
Cardiovascular · 15d
Cleared Aug 13, 2002
BRUNO ELECTRA-RIDE, MODEL SRE-2700
K022509 · ILK
Bruno Independent Living Aids, Inc.
Physical Medicine · 14d
Cleared Aug 13, 2002
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
K022567 · IYN
Acuson Corp.
Radiology · 11d
Cleared Aug 12, 2002
MODIFICATION TO RELIEF BRIEF
K003128 · NJB
The JM Kohn Co.
Physical Medicine · 675d
Cleared Aug 12, 2002
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 12, 2002
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 90d
Cleared Aug 12, 2002
PATXFER
K021583 · LLZ
Brainlab AG
Radiology · 90d
Cleared Aug 12, 2002
HALLU PLATES
K021626 · HRS
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 12, 2002
UKNEE TOTAL KNEE SYSTEM
K021657 · JWH
United Orthopedic Corp.
Orthopedic · 84d
Cleared Aug 12, 2002
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR...
K021659 · LYY
P.T. Healthcare Glovindo
General Hospital · 84d
Cleared Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662 · HWC
Magly Orthopedics, LLC
Orthopedic · 84d
Cleared Aug 12, 2002
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
K021668 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Aug 12, 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
K021720 · LPL
Soflex Isralens Contact Lens , Ltd.
Ophthalmic · 80d
Cleared Aug 12, 2002
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K021749 · NDF
Ebi, L.P.
Orthopedic · 76d
Cleared Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET...
K021902 · JQC
Medtronic Vascular
Hematology · 63d
Cleared Aug 12, 2002
MODIFICATION TO MEDSTATION
K021934 · LLZ
Aisoftw@Re Medical, S.P.A.
Radiology · 61d
Cleared Aug 12, 2002
FULCRUM
K021949 · LMA
Howtek, Inc.
Radiology · 60d
Cleared Aug 12, 2002
ALPHA INFUSION PUMP AND CATHETERS
K021964 · MEB
Advanced Infusion, Inc.
General Hospital · 59d
Cleared Aug 12, 2002
SYDNEY IVF CULTURE OIL
K022002 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 54d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218 · JDK
Spinal Concepts, Inc.
Orthopedic · 34d