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
162553–162576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1981
RESPIRATOR MONITOR
K813198 · CCL
Florida Medical Equipment Repair, Inc.
Anesthesiology · 25d
Cleared Dec 08, 1981
HEARING AID CUSTOM ITE
K813206 · ESD
Duvan Acoustics, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 08, 1981
Y-GLUTAMYLTRANSFERASE
K813215
American Monitor Corp.
Chemistry · 29d
Cleared Dec 08, 1981
TDX VANCOMYCIN
K813218 · LEH
Abbott Laboratories
Toxicology · 29d
Cleared Dec 08, 1981
HEARING AID MODEL UE9-R
K813229 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Dec 08, 1981
OHIO AIR ADAPTOR
K813234 · BYX
Timeter Instrument Corp.
Anesthesiology · 21d
Cleared Dec 08, 1981
DISS FEMALE AIR ADAPTOR
K813235 · BYK
Timeter Instrument Corp.
Anesthesiology · 21d
Cleared Dec 08, 1981
UV URIC ACID DETERMINATION
K813244 · CDO
Biorent Diagnostic, Inc.
Chemistry · 20d
Cleared Dec 08, 1981
CONPHAR DELEE HILLIS STETHOSCOPE
K813298 · HGN
Conphar, Inc.
Obstetrics & Gynecology · 15d
Cleared Dec 03, 1981
LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER
K812744 · HAW
Progress Mankind Technology
Neurology · 65d
Cleared Dec 03, 1981
INFANT PERCUSSOR #5534
K812803 · BYI
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 58d
Cleared Dec 03, 1981
MICROCOIL 80 DIALYZER
K812811 · FHS
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 03, 1981
CREATININE REAGENT SET
K812834 · CGX
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
TRIGLYCERIDE REAGENT SET
K812838 · CDT
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
HDL CHOLESTEROL REAGENT SET
K812839 · LBR
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
SERUM IRON REAGENT SET
K812840 · JIY
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
PTT-200 TELEPHONIC PULMONARY TRANSMITT
K812849 · BTY
Pharmaquest Corp.
Anesthesiology · 55d
Cleared Dec 03, 1981
PTT-200 PULMONARY RECEIVER/MICROPROCES
K812850 · BTY
Pharmaquest Corp.
Anesthesiology · 55d
Cleared Dec 03, 1981
SURGICAL MASK
K812992 · FXX
South Mountain Medical
General Hospital · 38d
Cleared Dec 03, 1981
FILTER FLOW MASK CAT. #300
K812996 · FXX
Eldredge Mfg. Co.
General Hospital · 38d
Cleared Dec 03, 1981
FILTER FLOW MASK CAT. #350
K812997 · FXX
Eldredge Mfg. Co.
General Hospital · 38d
Cleared Dec 03, 1981
WA1000
K813024 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 36d
Cleared Dec 03, 1981
PORTABLE OXYGEN GENERATOR
K813058 · CAW
Respiratory Marketing, Inc.
Anesthesiology · 34d
Cleared Dec 03, 1981
MOBIL-AID AUTOMATIC EXPOSURE CONTROL
K813128 · IZL
Advanced Instrument Development, Inc.
Radiology · 28d