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
63025–63048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 2006
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP...
K060466 · DJG
ACON Laboratories, Inc.
Toxicology · 58d
Cleared Apr 21, 2006
UNITY HUMERAL PLATE
K060545 · KTT
Tornier
Orthopedic · 51d
Cleared Apr 21, 2006
SPRAYGENIX CRYO ABLATION SYSTEM
K060555 · GEH
Crymed Technologies, Inc.
General & Plastic Surgery · 50d
Cleared Apr 21, 2006
BURBANK TENACULUM
K060573 · HDC
Vascular Control Systems, Inc.
Obstetrics & Gynecology · 46d
Cleared Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · KTT
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Apr 21, 2006
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE....
K060621 · JWY
Tds Holdings, Inc.
Microbiology · 44d
Cleared Apr 21, 2006
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
K060646 · EBZ
Monitex Industrial Co., Ltd.
Dental · 42d
Cleared Apr 21, 2006
SURTRAK IMPLANTATION KIT
K060679 · KXK
North American Scientific, Inc.
Radiology · 37d
Cleared Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768 · JIN
Abbott Diabetes Care, Inc.
Chemistry · 30d
Cleared Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
K060774 · CGN
Beckman Coulter, Inc.
Chemistry · 30d
Cleared Apr 21, 2006
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · FRN
Hospira, Inc.
General Hospital · 28d
Cleared Apr 21, 2006
HL888SF
K060835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 25d
Cleared Apr 21, 2006
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
K060954 · DQK
St. Jude Medical, Inc.-Endocardial...
Cardiovascular · 14d
Cleared Apr 20, 2006
LADY COMP USA
K050094 · LHD
Lady Comp USA
Obstetrics & Gynecology · 461d
Cleared Apr 20, 2006
COMFORT/IO IONTOPHORESIS ELECTRODES
K060579 · EGJ
Pepin Mfg., Inc.
Physical Medicine · 45d
Cleared Apr 20, 2006
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
K060625 · HCG
Micro Therapeutics, Inc.
Neurology · 42d
Cleared Apr 20, 2006
MODIFICATION TO HEALTH BUDDY APPLIANCE
K060843 · DQA
Health Hero Network, Inc.
Anesthesiology · 23d
Cleared Apr 19, 2006
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
K052947 · JAQ
Source Production & Equipment Co., Inc.
Radiology · 181d
Cleared Apr 19, 2006
IVIEW
K053306 · IYO
Ondemandsoft
Radiology · 142d
Cleared Apr 19, 2006
RESCUE IMPLANT SYSTEM
K053353 · DZE
Megagen Co., Ltd.
Dental · 138d
Cleared Apr 19, 2006
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K053356 · DXJ
Ge Medical Systems Information...
Cardiovascular · 138d
Cleared Apr 19, 2006
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
K053599 · CBR
Spacelabs Medical, Inc.
Anesthesiology · 117d
Cleared Apr 19, 2006
ABARIS
K053610 · JAK
Traxtal Technologies, Inc.
Radiology · 113d
Cleared Apr 19, 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K060052 · JAK
Ge Medical Systems, LLC
Radiology · 103d