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
58273–58296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2007
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222,...
K071493 · NBW
Taidoc Technology Corporation
Chemistry · 149d
Cleared Oct 26, 2007
BEMITT, MODEL 0001
K071787 · IZH
Dja Distributors, LLC
Radiology · 116d
Cleared Oct 26, 2007
BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
K071981 · ELC
Bonart Co., Ltd.
Dental · 100d
Cleared Oct 26, 2007
RNK ELECTRONIC STETHOSCOPE
K072026 · DQD
Rnk Products, Inc.
Cardiovascular · 94d
Cleared Oct 26, 2007
KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
K072063 · MBI
Kfx Medical
Orthopedic · 91d
Cleared Oct 26, 2007
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
K072086 · OAT
D B Orthodontics, Ltd.
Dental · 88d
Cleared Oct 26, 2007
STIMLAB
K072200 · JOQ
Micropace Pty, Ltd.
Cardiovascular · 79d
Cleared Oct 26, 2007
GENTLERAY 980 DIODE LASER SYSTEM
K072262 · GEX
Kavo America
General & Plastic Surgery · 72d
Cleared Oct 26, 2007
EXACTRAC 5.5
K072506 · IYE
Brainlab AG
Radiology · 50d
Cleared Oct 26, 2007
TRACKPORT
K072529 · IYE
Direx Systems Corp.
Radiology · 49d
Cleared Oct 26, 2007
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
K072545 · EBF
Pentron Clinical Technologies
Dental · 46d
Cleared Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND...
K072612 · MOI
Beckman Coulter, Inc.
Immunology · 39d
Cleared Oct 26, 2007
INRATIO 2 PT MONITORING SYSTEM
K072727 · GJS
Hemosense, Inc.
Hematology · 30d
Cleared Oct 26, 2007
EXCELARREST FOAM
K072900 · QSY
Hemostasis, LLC
General & Plastic Surgery · 15d
Cleared Oct 25, 2007
HEMOCUE WBC SYSTEM
K071652 · GKL
Hemocue AB
Hematology · 129d
Cleared Oct 25, 2007
GENERAL SEMEN ANALYSIS KIT
K071737 · POV
Dyn-Bioshaf (2006) , Ltd.
Hematology · 121d
Cleared Oct 25, 2007
DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
K071904 · CAW
Carleton Life Support Systems, Inc.
Anesthesiology · 107d
Cleared Oct 25, 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Oct 25, 2007
CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
K072191 · KPS
Gvi Technology Partners
Radiology · 80d
Cleared Oct 25, 2007
SYSTEM-MINI, MODELS: 390, E30
K072294 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 70d
Cleared Oct 25, 2007
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
K072472 · LYZ
Xuzhou Full Sun Medical Products , Ltd.
General Hospital · 51d
Cleared Oct 25, 2007
DRYSTAR AXYS, MODEL EYZ4E
K072680 · LMC
Agfa Healthcare Corporation
Radiology · 31d
Cleared Oct 25, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K072800 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 24d
Cleared Oct 25, 2007
HEXAPOD EVO RT COUCH TOP
K072898 · JAI
Medical Intelligence Medizintechnik GmbH
Radiology · 14d