FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168553–168576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 17, 1979
BARD URODYNAMIC CATHETERS
K791717 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 12, 1979
VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.
K770428 · FSM
Holco Instrument Corp.
General & Plastic Surgery · 919d
Cleared Sep 12, 1979
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · DFH
Kent Laboratories, Inc.
Immunology · 153d
Cleared Sep 12, 1979
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
K791150 · GWQ
Nihon Kohden America, Inc.
Neurology · 89d
Cleared Sep 12, 1979
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
K791233 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Sep 12, 1979
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
K791234 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d