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
170089–170112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1979
STAO-HOTPACK
K790904 · IMA
Staodynamics, Inc.
Physical Medicine · 7d
Cleared May 17, 1979
CARDIOTEST 2200
K790503 · DTA
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared May 17, 1979
ACCOR MATRIX
K790633 · DZN
Accor, Inc.
Dental · 44d
Cleared May 17, 1979
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
K790846 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 13d
Cleared May 17, 1979
CARDIO-SLIDECOMP
K790869 · DPS
Creative Instruments
Cardiovascular · 10d
Cleared May 17, 1979
FACE TENT-VINYL
K790884
Airlife, Inc.
Cardiovascular · 10d
Cleared May 17, 1979
NASAL, OXYGEN, CANNULA
K790885 · CAT
Airlife, Inc.
Anesthesiology · 10d
Cleared May 17, 1979
CORRUGATED FLEXIBLE POLYETHYLENE
K790886
Airlife, Inc.
Cardiovascular · 10d
Cleared May 17, 1979
CIRCUIT, BREATHING (W CONNEC, Y PIECE)
K790889
Airlife, Inc.
Cardiovascular · 10d
Cleared May 16, 1979
TEST CELLS
K790249 · KSF
Hyland Therapeutic Div., Travenol...
Hematology · 97d
Cleared May 16, 1979
MICROTEC BACTERIAL FILTER
K790407 · DRS
Medex, Inc.
Cardiovascular · 79d
Cleared May 16, 1979
FINESSE
K790585 · EBF
L.D. Caulk Co.
Dental · 50d
Cleared May 16, 1979
CHEMBOND
K790586 · EMA
L.D. Caulk Co.
Dental · 50d
Cleared May 16, 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · DXY
Cordis Corp.
Cardiovascular · 36d
Cleared May 16, 1979
HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID
K790737 · ESD
Hearing Services, Inc.
Ear, Nose, Throat · 30d
Cleared May 16, 1979
COLOSTOMY ENEMA DEVICE
K790749 · EXD
Vabar Corp.
Gastroenterology & Urology · 29d
Cleared May 16, 1979
MODEL H39C-BEHING-THE-EAR HEARING INSTRU
K790779
Marcon Hearing Instruments, Inc.
Gastroenterology & Urology · 23d
Cleared May 16, 1979
ARRHYTHMIA II CARDULE
K790837 · DSI
Spacelabs, Inc.
Cardiovascular · 16d
Cleared May 15, 1979
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · FRN
Travenol Laboratories, S.A.
General Hospital · 90d
Cleared May 15, 1979
ROCHE LACTATE ANALYZER 640
K790421 · KHP
Roche Medical Electronics, Inc.
Chemistry · 76d
Cleared May 15, 1979
GAMMA SMAC REAGENTS
K790578 · CIG
Gamma Enterprises, Inc.
Chemistry · 49d
Cleared May 15, 1979
CHROMATOGRAPHY TUBES
K790581 · CDP
Miles Laboratories, Inc.
Chemistry · 49d
Cleared May 15, 1979
ASSAY REAGENTS, LSA 290
K790588 · JEW
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared May 15, 1979
CENTRIFICHEM INORGANIC PHOSPHORUS
K790662 · CED
Union Carbide Corp.
Chemistry · 39d