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
59785–59808 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2007
ORION
K070231 · HKI
Nidek Technologies Srl
Ophthalmic · 90d
Cleared Apr 24, 2007
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
K070311 · GEI
Medtronic Vascular
General & Plastic Surgery · 82d
Cleared Apr 24, 2007
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
K070330 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Apr 24, 2007
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
K070398 · FRN
Hospira, Inc.
General Hospital · 71d
Cleared Apr 24, 2007
MODIFIED MERCY RETRIEVER, MODEL 90070
K070521 · NRY
Concentric Medical, Inc.
Neurology · 60d
Cleared Apr 24, 2007
RETROPAN CCD-TWAIN-USB
K070535 · MUH
Video Dental Concepts, Inc.
Radiology · 57d
Cleared Apr 24, 2007
C!
K070589 · KPS
Transphoton Corporation
Radiology · 54d
Cleared Apr 24, 2007
VISIO+CD VIEWER# KPSCDVE01
K070606 · LLZ
Keosys Sas
Radiology · 50d
Cleared Apr 24, 2007
INCIRCLE BI-POLAR RF ABLATION SYSTEM
K070711 · GEI
Rfa Medical, Inc.
General & Plastic Surgery · 41d
Cleared Apr 24, 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776 · HQF
Quantel Medical
Ophthalmic · 34d
Cleared Apr 24, 2007
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K070839 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 28d
Cleared Apr 24, 2007
BARD MALECOT AND PEZZER DRAINS
K070879 · FEW
C.R. Bard, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 24, 2007
ENSEAL PTC TISSUE SEALING DEVICE
K070896 · GEI
Surgrx, Inc.
General & Plastic Surgery · 22d
Cleared Apr 23, 2007
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · JFY
Diazyme Laboratories
Chemistry · 273d
Cleared Apr 23, 2007
MEDILASER, MODEL 1000
K063745 · ILY
Laser Thera, LLC
Physical Medicine · 125d
Cleared Apr 23, 2007
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER...
K063758 · BTT
Teleflex Medical
Anesthesiology · 125d
Cleared Apr 23, 2007
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL#...
K063766 · DDG
Good Biotech Corp.
Immunology · 124d
Cleared Apr 23, 2007
ACCENT
K070004 · GEI
Alma Lasers , Ltd.
General & Plastic Surgery · 110d
Cleared Apr 23, 2007
VV FLUORO 3D
K070106 · HAW
Brainlab AG
Neurology · 102d
Cleared Apr 23, 2007
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022,...
K070203 · MEG
Inviro Medical Devices, Inc.
General Hospital · 91d
Cleared Apr 23, 2007
QUICK VUE RSV TEST, MODELS 20193, 20199
K070747 · GQG
Quidel Corp.
Microbiology · 35d
Cleared Apr 23, 2007
MODIFICATION TO ARTHROCARE ARTHROWANDS
K070958 · GEI
Arthrocare Corp.
General & Plastic Surgery · 18d
Cleared Apr 20, 2007
COOK CELECT VENA CAVA FILTER
K061815 · DTK
William Cook Europe Aps
Cardiovascular · 297d
Cleared Apr 20, 2007
TALKING TRACH
K062104 · BTO
Engineered Medical Systems, Inc.
Anesthesiology · 270d