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
169393–169416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1979
BRILLIANT GREEN AGAR
K791593 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Sep 17, 1979
CYSTINE TRYPTIC AGAR
K791594 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Sep 17, 1979
BAIRD-PARKER AGAR
K791595 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Sep 17, 1979
WAKO TRIGLYCERIDE
K791597 · CDT
Wako Pure Chemical Industries, Ltd.
Chemistry · 33d
Cleared Sep 17, 1979
GELMAN LIPOPROTEIN FRS SET. P/N 51213
K791606 · JHO
Gelman Sciences, Inc.
Chemistry · 28d
Cleared Sep 17, 1979
UC-2000 UTERINE CATHERIZATION SYSTEM
K791633 · HFO
Life Support, Inc.
Obstetrics & Gynecology · 27d
Cleared Sep 17, 1979
AO STYLET LARYNGOSCOPE, MODEL SLS-1
K791634 · CAL
American Optical Corp.
Anesthesiology · 27d
Cleared Sep 17, 1979
MODEL 54 FLOWMETER BACK-PRESSURE TUBE
K791648 · CAX
Harris Calorific
Anesthesiology · 24d
Cleared Sep 17, 1979
HUMAN, C-REACTIVE PROTEIN (CRP)
K791650 · DCK
Beckman Instruments, Inc.
Immunology · 27d
Cleared Sep 17, 1979
NORMAL CONTROL
K791654 · JJY
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Sep 17, 1979
CPK ISOENZYME REAGENT
K791655 · JHY
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Sep 17, 1979
ENZYME STABILIZING REAGENT (ESR)
K791656 · CFE
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Sep 17, 1979
LDH ISOENZYME REAGENT
K791657 · CFE
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Sep 17, 1979
STERILE WATER FOR RESPIRATORY THERAPY
K791683 · BTT
Abbott Laboratories
Anesthesiology · 20d
Cleared Sep 17, 1979
GLUCOSE REAGENT
K791685 · CGA
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CO2 CUP REAGENT
K791686 · JFL
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CO2 REFERENCE REAGENT
K791687 · JFL
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
ALKALINE BUFFER
K791688 · CGX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
PICRIC SOLUTION
K791689 · CGX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CHOLORDE REAGENT
K791690 · JFS
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM CONDITIONING SOLUTION
K791691 · JGS
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
SODIUM/POTASSIUM BUFFER SOLUTION
K791692 · CEM
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR I
K791693 · JIX
Hi Chem, Inc.
Chemistry · 48d
Cleared Sep 17, 1979
CALIBRATOR II
K791694 · JIX
Hi Chem, Inc.
Chemistry · 48d