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
161953–161976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1981
SOFTCARE BARRIER WET DRESSING
K812736 · EFQ
The Kendal Co.
General & Plastic Surgery · 38d
Cleared Nov 06, 1981
TRIDENT #2001
K812769 · GEI
Trident Surgical Corp.
General & Plastic Surgery · 32d
Cleared Nov 06, 1981
FLUORICON L300 IMAGE INTENSIFIER
K812775 · JAA
General Electric Co.
Radiology · 32d
Cleared Nov 06, 1981
STERILE ADHERENT DRAPES
K812809 · KKX
Abco Dealers, Inc.
General Hospital · 31d
Cleared Nov 06, 1981
ZEE SURGICAL INSTRUMENTS
K812814 · GDZ
Zee Medical Products Co., Inc.
General & Plastic Surgery · 31d
Cleared Nov 06, 1981
SURGICAL DRESSINGS
K812831 · GDY
Foreign Trade Zone of Wisconsin
General & Plastic Surgery · 28d
Cleared Nov 06, 1981
VENTRONICS #5590 ECII OXYGEN MONITOR
K812854 · CCL
Ventronics, Div of Hudson Oxygen...
Anesthesiology · 24d
Cleared Nov 06, 1981
VENTRONICS #5595 ECII OXYGEN ANALYZER
K812855 · CCL
Ventronics, Div of Hudson Oxygen...
Anesthesiology · 24d
Cleared Nov 06, 1981
CHEMICAL INDICATORS
K812856 · JOJ
Sterilization Technical Services, Inc.
General Hospital · 24d
Cleared Nov 06, 1981
FETASONDE 5, #30, CENTRAL NURSING STAT
K812863 · HGM
Kontron Instruments, Inc.
Obstetrics & Gynecology · 24d
Cleared Nov 06, 1981
VDRL CARBON ANTIGEN
K812894 · GMQ
Oxoid U.S.A., Inc.
Microbiology · 22d
Cleared Nov 06, 1981
MED-EX
K812899 · LBB
Chattanooga Group, Inc.
Neurology · 21d
Cleared Nov 06, 1981
MEDISYSTEMS NEEDLES & SYRINGES
K812910 · FMI
Medisystems Corp.
General Hospital · 18d
Cleared Nov 06, 1981
BCYE MEDIUM
K812911 · JSE
Gibco Laboratories Life Technologies,...
Microbiology · 18d
Cleared Nov 06, 1981
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
K812916 · JTN
General Diagnostics
Microbiology · 18d
Cleared Nov 06, 1981
PORTABLE LIDOCAINE INFUSION PUMP
K812917 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 18d
Cleared Nov 06, 1981
PILLING K KNIFE
K812918 · HNN
Narco Scientific
Ophthalmic · 18d
Cleared Nov 06, 1981
S/P SURE-CAP
K812921 · GIO
American Dade
Hematology · 18d
Cleared Nov 06, 1981
S/P SURE-CAP C
K812922 · GIO
American Dade
Hematology · 18d
Cleared Nov 06, 1981
S/P SURE-CAP N
K812923 · GIO
American Dade
Hematology · 18d
Cleared Nov 06, 1981
ALT-QUANTICHROM
K812926 · CKA
Abbott Laboratories
Chemistry · 18d
Cleared Nov 06, 1981
ARTERIOGRAM TRAY
K812927 · FMG
American Pharmaseal Div. Ahsc
Radiology · 18d
Cleared Nov 06, 1981
LANCER SPECIMEN CONTAINER
K812933 · FMH
Sherwood Medical Co.
General Hospital · 17d
Cleared Nov 06, 1981
MONOJECT PREFILLED SYRINGES
K812934 · FMF
Sherwood Medical Co.
General Hospital · 17d