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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46705–46728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Aug 19, 2011
VITALA CONTINENCE CONTROL DEVICE
K111365 · EZQ
Convatec, Inc.
Gastroenterology & Urology · 95d
Cleared Aug 19, 2011
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
K111432 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Aug 19, 2011
UNIMAX VERESS NEEDLE
K111441 · HIF
Unimax Medical Systems, Inc.
Obstetrics & Gynecology · 87d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · MWP
Hologic, Inc.
Radiology · 79d
Cleared Aug 19, 2011
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC...
K111550 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 77d
Cleared Aug 19, 2011
E-CUBE
K111616 · EKX
Saeshin Precision Co., Ltd.
Dental · 70d
Cleared Aug 19, 2011
P200T
K111628 · MYC
Optos Plc.
Ophthalmic · 70d
Cleared Aug 19, 2011
ARTHREX SCAPHOLUNATE ANCHOR
K111661 · MBI
Arthrex, Inc.
Orthopedic · 66d
Cleared Aug 19, 2011
CAVIOS CAVITY LINER
K111668 · EJK
Neodental Chemical Products Co., Ltd.
Dental · 66d
Cleared Aug 19, 2011
PROFEMUR(R) E CEMENTLESS HIP STEM
K111698 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Aug 19, 2011
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
K111699 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Aug 19, 2011
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799 · HWC
Ascension Orthopedic
Orthopedic · 53d
Cleared Aug 19, 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952 · JIT
Beckman Coulter, Inc.
Chemistry · 39d
Cleared Aug 19, 2011
POLARIS SPINAL SYSTEM
K111957 · NKB
Biomet Spine (Ebi, LLC)
Orthopedic · 39d
Cleared Aug 19, 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · MNI
Spineart
Orthopedic · 28d
Cleared Aug 19, 2011
MICROCATHETER
K112124 · DQO
Navilyst Medical, Inc.
Cardiovascular · 25d
Cleared Aug 19, 2011
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
K112231 · GXI
Lccs Products Limited
Neurology · 15d
Cleared Aug 18, 2011
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K102394 · MLR
STERIS Corporation
General Hospital · 360d
Cleared Aug 18, 2011
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K103274 · MOS
Sentinelle Medical, Inc.
Radiology · 286d
Cleared Aug 18, 2011
CS 9300, CS 9300C
K103659 · OAS
Trophy
Radiology · 246d
Cleared Aug 18, 2011
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673 · MHI
Techlab Inc., Corporate Research Center
Microbiology · 245d
Cleared Aug 18, 2011
ACE TRIMARK TRICAM DENTAL IMPLANT
K103790 · DZE
Ace Surgical Supply Company, Inc.
Dental · 234d
Cleared Aug 18, 2011
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · OWQ
Sterilmed, Inc.
Cardiovascular · 219d
Cleared Aug 18, 2011
AXIS-SHIELD ANTI-CCP
K110296 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 198d