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
56041–56064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2008
MICROSHEATH LP AND LP-AT
K080849 · DQY
Flowcardia, Inc.
Cardiovascular · 121d
Cleared Jul 25, 2008
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
K080922 · BZQ
Salter Labs, Division of Regulatory...
Anesthesiology · 115d
Cleared Jul 25, 2008
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
K080969 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 112d
Cleared Jul 25, 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · JJX
Bionostics, Inc.
Chemistry · 67d
Cleared Jul 25, 2008
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K081506 · CBF
Hyperbaric America, LLC
Anesthesiology · 57d
Cleared Jul 25, 2008
FORA TD-3224 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K081714 · CGA
Taidoc Technology Corporation
Chemistry · 37d
Cleared Jul 25, 2008
EXPRESS CHEST DRAIN
K081718 · KDQ
Atrium Medical Corp.
General Hospital · 37d
Cleared Jul 25, 2008
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH...
K081826 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 28d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 24, 2008
SURGICRAFT SURGICAL MESH SYSTEM
K072370 · FTL
Surgicraft , Ltd.
General & Plastic Surgery · 336d
Cleared Jul 24, 2008
MEDELA INVIA WOUND THERAPY
K080357 · OMP
Medela AG
General & Plastic Surgery · 164d
Cleared Jul 24, 2008
ACTITRAINER
K080545 · ISD
Actigraph, LLC
Physical Medicine · 148d
Cleared Jul 24, 2008
VOCO PROFLUORID VARNISH
K080814 · LBH
Voco GmbH
Dental · 122d
Cleared Jul 24, 2008
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
K081325 · JWY
Ab Biodisk
Microbiology · 73d
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 24, 2008
MEG LAPAROSCOPIC ELECTRODES
K081431 · GEI
Bovie Medical
General & Plastic Surgery · 64d
Cleared Jul 24, 2008
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
K081790 · MNI
Trinity Orthopedics, LLC
Orthopedic · 29d
Cleared Jul 23, 2008
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS
K063841 · MRR
Liposcience
Chemistry · 575d
Cleared Jul 23, 2008
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
K073159 · HWC
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 258d
Cleared Jul 23, 2008
ZENIEVA
K073246 · NAE
Gorbec Pharmaceutical Services, Inc.
General & Plastic Surgery · 247d
Cleared Jul 23, 2008
FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE
K073616 · GEI
Electromedics Co. , Ltd.
General & Plastic Surgery · 210d
Cleared Jul 23, 2008
MEDELA THOPAZ, MODEL 200 0288
K080212 · BTA
Medela AG
General & Plastic Surgery · 176d
Cleared Jul 23, 2008
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
K080463 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 154d
Cleared Jul 23, 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR...
K080512 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 149d