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

Filters: Cleared only ×
176,076 results
65113–65136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 2005
QUANTIA IGE
K050493 · DGC
Biokit, S.A.
Immunology · 169d
Cleared Aug 16, 2005
QUANTIA BETA-2 MICROGLOBULIN
K050613 · JZG
Biokit, S.A.
Immunology · 159d
Cleared Aug 16, 2005
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
K050821 · KQG
Zycare
Hematology · 138d
Cleared Aug 16, 2005
MODIFICATION TO DUET SYSTEM
K050840 · JOY
Bioview , Ltd.
Hematology · 137d
Cleared Aug 16, 2005
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K050971 · LZG
Biovalve Technologies, Inc.
General Hospital · 120d
Cleared Aug 16, 2005
55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K051095 · LPL
Optical Connection, Inc.
Ophthalmic · 110d
Cleared Aug 16, 2005
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
K051282 · NOT
Tripath Imaging, Inc.
Pathology · 91d
Cleared Aug 16, 2005
VPAP ADAPT
K051364 · MNS
Resmed, Ltd.
Anesthesiology · 83d
Cleared Aug 16, 2005
URITEK-720+ URINE ANALYZER
K051526 · KQO
Teco Diagnostics
Chemistry · 69d
Cleared Aug 16, 2005
CD-CHEX PLUS BC
K051633 · GGL
Streck
Hematology · 57d
Cleared Aug 16, 2005
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
K051794 · NVQ
Office of the Surgeon General, U.S. Army
Microbiology · 46d
Cleared Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
K051849 · LON
bioMerieux, Inc.
Microbiology · 40d
Cleared Aug 16, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED)
K051923 · LYZ
Shijiazhuang Wonder Plastic Co., Ltd.
General Hospital · 32d
Cleared Aug 16, 2005
DRUG ACCESS SPIKE
K051930 · FMF
Medegen Medical Manufacturing Services
General Hospital · 34d
Cleared Aug 16, 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · FMF
Terumo Medical Corp.
General Hospital · 19d
Cleared Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · LIT
Boston Scientific Corporation
Cardiovascular · 19d
Cleared Aug 16, 2005
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · FGB
Acmi Corporation
Gastroenterology & Urology · 19d
Cleared Aug 16, 2005
TSRH SPINAL SYSTEM
K052054 · NKB
Medtronic Sofamor Danek
Orthopedic · 18d
Cleared Aug 16, 2005
LYSUS INFUSION SYSTEM
K052071 · QEY
Ekos Corp.
Cardiovascular · 15d
Cleared Aug 16, 2005
G-SCAN CERVICAL SPINE COIL
K052077 · MOS
Esaote, S.P.A.
Radiology · 15d
Cleared Aug 16, 2005
NUBIC SPINAL IMPLANT
K052096 · MQP
Signus Medical, LLC
Orthopedic · 13d
Cleared Aug 16, 2005
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · FRC
3M Company
General Hospital · 11d
Cleared Aug 16, 2005
RX ACCUNET EMBOLIC PROTECTION SYSTEM
K052165 · NTE
Guidant Corporation
Cardiovascular · 7d
Cleared Aug 15, 2005
3L SURGICAL DRAPES
K043015 · KKX
3l Medical Products Co., Ltd.
General Hospital · 286d