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

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176,076 results
163945–163968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1981
RMI TRANSILLUMINATION LIGHT METER #295
K811108 · HJM
Radiation Measurements, Inc.
Radiology · 69d
Cleared Jul 01, 1981
SUPERFLOW CANNULA FOR ARTHROS. SURGERY
K811115
The Anspach Effort, Inc.
General & Plastic Surgery · 69d
Cleared Jul 01, 1981
DENVER PERITONEO-VENOUS SHUNT
K811183 · KPM
Denver Biomedicals, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 01, 1981
ACMI ASPIRATOR KIT #8808
K811218 · EOQ
American Cystocope Makers, Inc.
Ear, Nose, Throat · 58d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350 · DXY
Medtronic Vascular
Cardiovascular · 49d
Cleared Jul 01, 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449 · KSR
Haemonetics Corp.
Hematology · 40d
Cleared Jul 01, 1981
AQUACADE
K811524 · LHC
Respiratory Care, Inc.
General Hospital · 33d
Cleared Jul 01, 1981
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL
K811539 · DTB
Cordis Corp.
Cardiovascular · 30d
Cleared Jul 01, 1981
DENTAL FLOSS HOLDER
K811555 · JES
Sewon Industry
Dental · 29d
Cleared Jul 01, 1981
DAHLBERG MODEL AP HEARING AID
K811578 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 26d
Cleared Jul 01, 1981
LIQUIZYME SINGLE SOLUTION GLUCOSE REAG
K811592 · CGA
Amresco, Inc.
Chemistry · 23d
Cleared Jul 01, 1981
MEDDARS/ULTRA IMAGER PULSE/PHON MODULE
K811626 · DQC
Honeywell, Inc.
Cardiovascular · 22d
Cleared Jul 01, 1981
KINEMATIC ROTATING HINGE TOTAL KNEE PR.
K811630 · LGE
Howmedica Corp.
Orthopedic · 22d
Cleared Jul 01, 1981
MYELOSTAT DORSAL CORD STIMULATOR
K811655 · GZB
Medtronic Vascular
Neurology · 20d
Cleared Jul 01, 1981
P.D. CRADLE
K811657
Lung Care, Inc.
Physical Medicine · 20d
Cleared Jul 01, 1981
DURAFILL MICROFILL RESTORATIVE MATERIAL
K811669 · EBF
Kulzer, Inc.
Dental · 16d
Cleared Jul 01, 1981
URIC ACID TEST
K811687 · KNK
King Diagnostics, Inc.
Chemistry · 16d
Cleared Jul 01, 1981
CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT
K811694 · CKA
Baker Instructions Corp.
Chemistry · 16d
Cleared Jul 01, 1981
HELENA FETAL-TEK 200 MARKER
K811695 · JJY
Helena Laboratories
Chemistry · 15d
Cleared Jul 01, 1981
IL #781, SEMI-AUTOMATED LOADER
K811696 · JQW
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Jul 01, 1981
CHLORIDE/CARBON DIOXIDE RATE REAGENT
K811701 · JFS
Chem-Elec, Inc.
Chemistry · 15d
Cleared Jul 01, 1981
MULTITUBULAR AIR SPLINT KIT
K811704 · IQI
Roger Cestac & Assoc.
Physical Medicine · 15d
Cleared Jul 01, 1981
UNIVERSAL ADAPTER SYSTEM-U/ADAPIT
K811708 · BZA
Airlife, Inc.
Anesthesiology · 15d
Cleared Jul 01, 1981
PEDIATRIC OXYGEN MASKS
K811711 · BYG
Airlife, Inc.
Anesthesiology · 14d