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
77353–77376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED...
K013824 · ELM
Dental Manufacturing S.P.A
Dental · 72d
Cleared Jan 30, 2002
D.SIGN 53, MODEL NA1012204
K014082 · EJS
Ivoclar Vivadent, Inc.
Dental · 50d
Cleared Jan 30, 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · DSB
Sorba Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 30, 2002
RAVEN BACTERIAL SPORE STRIPS
K020026 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 26d
Cleared Jan 30, 2002
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 23d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jan 29, 2002
CORTISOL LIA
K010790 · CGR
Kmi Diagnostics, Inc.
Chemistry · 320d
Cleared Jan 29, 2002
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
K011950 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 222d
Cleared Jan 29, 2002
METAVISION CLINICAL INFORMATION SYSTEM
K012349 · MWI
Imdsoft, Ltd.
Cardiovascular · 189d
Cleared Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · BZD
Respironics, Inc.
Anesthesiology · 174d
Cleared Jan 29, 2002
CIC-C1Q EIA
K012576 · DAK
American Laboratory Products Co., Ltd.
Immunology · 173d
Cleared Jan 29, 2002
THERMAGE THERMACOOL TC SYSTEM
K013639 · GEI
Thermage, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER...
K013641 · GEI
Senorx, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d
Cleared Jan 29, 2002
RHODIA BITE REGISTRATION MATERIAL
K013859 · ELW
Rhodia, Inc.
Dental · 69d
Cleared Jan 29, 2002
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
K013959 · DKB
Bayer Diagnostics Corp.
Toxicology · 60d
Cleared Jan 29, 2002
JETSONIC 2000
K014245 · KOJ
Deldent , Ltd.
Dental · 34d
Cleared Jan 29, 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 26d
Cleared Jan 29, 2002
COOLBLU2 DENTAL RESIN CURING DEVICE
K020171 · EBZ
Dental Systems.Com, Inc.
Dental · 12d
Cleared Jan 28, 2002
SALINE IV FLUSH SYRINGE
K002142 · FOZ
Emt-Rx
General Hospital · 560d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · MQP
Implex Corp.
Orthopedic · 354d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 255d
Cleared Jan 28, 2002
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
K012089 · DQK
Catheffects, LLC
Cardiovascular · 207d
Cleared Jan 28, 2002
EXCITE SELF ETCH
K013584 · KLE
Ivoclar Vivadent, Inc.
Dental · 90d