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
175057–175080 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1976
ENZYMATIC TRIGLYCERIDES (END POINT)
K761200 · CDT
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Dec 21, 1976
LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)
K761210 · DRW
Physio-Control Corp.
Cardiovascular · 14d
Cleared Dec 21, 1976
CPK1SOENZYMES DETERMINATION PRO. #715-EP
K761212 · JHY
Sigma Chemical Co.
Chemistry · 14d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761217 · CEK
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
AUTO TOTAL BILIRUBIN REAGENT
K761218 · CIG
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
K761232 · KHE
Laboratory Diagnostics Co., Inc.
Hematology · 11d
Cleared Dec 21, 1976
ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5
K761237 · DXY
Arco Medical Products Co.
Cardiovascular · 8d
Cleared Dec 21, 1976
ELECTROPHORESIS ACCESSORY MO. 3526
K761248 · JJN
Gilford Instrument Laboratories, Inc.
Chemistry · 8d
Cleared Dec 21, 1976
RADIO TRANSPARENT ECG ELECTRODE
K761249 · DRX
Concept, Inc.
Cardiovascular · 8d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761257 · CEK
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
G.E. TELEMETRY MONITORING
K761259 · GYE
General Electric Co.
Neurology · 6d
Cleared Dec 21, 1976
VARIPLAN COMPUT. RADIOTHERAPY
K761265 · KPQ
Varian Assoc., Inc.
Radiology · 5d
Cleared Dec 19, 1976
RAPI/TEX-LGM KIT
K760673 · DFT
Hoechst-Roussel Pharmaceuticals, Inc.
Immunology · 90d
Cleared Dec 17, 1976
CENTRAL STATION REPEATER (MODEL 8032A)
K760968 · KXN
Hewlett-Packard Co.
Obstetrics & Gynecology · 43d
Cleared Dec 17, 1976
DEPUY MODIFIED SKELETAL TRACTION PIN
K761088 · JEC
Depuy, Inc.
Orthopedic · 25d
Cleared Dec 17, 1976
RELY TAMPON
K761184 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 14d
Cleared Dec 17, 1976
DYNATECH JD7/JD7P COLPOSCOPE
K761205 · HEX
Dynatech Cryomedical Co.
Obstetrics & Gynecology · 10d
Cleared Dec 17, 1976
TECA MODEL SP5/T ELECTRO-THER. STIM.
K761220 · IPF
Teca, Inc.
Physical Medicine · 10d
Cleared Dec 17, 1976
AMMOCENTESIS TRAY (KIT)
K761230 · HIO
Pharmaseal Div., Baxter Healthcare Corp.
Obstetrics & Gynecology · 7d
Cleared Dec 17, 1976
STAYFREE MAXI PADS
K761233 · HHL
Personal Products Co.
Obstetrics & Gynecology · 7d
Cleared Dec 16, 1976
CLEANSING AGENT, NEW WOUND (DEBRISSU)
K760469 · KOZ
Pharmaseal Laboratories
General & Plastic Surgery · 119d
Cleared Dec 16, 1976
TABLE, UROSURGICAL
K760522 · KQS
Mallinckrodt Group, Inc.
Gastroenterology & Urology · 112d
Cleared Dec 16, 1976
JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S
K760652 · EOX
Pilling Co.
Ear, Nose, Throat · 92d
Cleared Dec 16, 1976
REMOTE CONTROL SYSTEM FOR MICROSCOPE
K760696 · EPT
Alcon Laboratories
General & Plastic Surgery · 85d