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
169777–169800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1979
LAP SPONGE
K782107 · GDY
Carapace, Inc.
General & Plastic Surgery · 59d
Cleared Feb 16, 1979
NEEDLE, BURRON FILTER
K790061 · GAA
National Patent Development Corp.
General & Plastic Surgery · 37d
Cleared Feb 16, 1979
TINNITUS DEVICES
K790064 · ETS
Vicon Instrument Co.
Ear, Nose, Throat · 32d
Cleared Feb 16, 1979
AMP AUTOMATIC CYCLER STAND
K790091 · KPF
American Medical Products, Inc.
Gastroenterology & Urology · 31d
Cleared Feb 16, 1979
MONITOR, OFFICE MODEL 140
K790139 · HGM
Ge Medical Systems Information...
Radiology · 28d
Cleared Feb 16, 1979
AEROSOL MASK
K790163 · BYG
Airlife, Inc.
Anesthesiology · 35d
Cleared Feb 16, 1979
MODEL V 4207 INTEGRATING PLUG-IN
K790185 · BZC
Electronics For Medicine, Inc.
Anesthesiology · 18d
Cleared Feb 16, 1979
PADIATRY PACK & SHEET WITH FABRIC 450
K790224 · KKX
Surgikos, Inc.
General Hospital · 14d
Cleared Feb 15, 1979
HEPARIN ASSAY
K781479 · KFF
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 171d
Cleared Feb 15, 1979
DAP-PAK
K781755 · KDJ
Dravon Medical, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 15, 1979
IRRIGATOR, BODY CAVITY
K781918 · EYN
Bci, Inc.
General & Plastic Surgery · 94d
Cleared Feb 15, 1979
ANALYZER, OXYGEN MODEL M25RA & M25RAD
K782062 · CCL
Catalyst Research Corp.
Anesthesiology · 70d
Cleared Feb 15, 1979
RIA KIT, SISOMICIN
K782126 · DJB
Diagnostic Products Corp.
Toxicology · 50d
Cleared Feb 15, 1979
MINI-DILUTER 2
K782130 · JQW
Dynatech Laboratories, Inc.
Chemistry · 50d
Cleared Feb 15, 1979
FLUROMETER, DADE
K782150 · JZT
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 51d
Cleared Feb 15, 1979
SERACON-LP
K782170 · JJX
Bhp Diagnostix, Inc.
Chemistry · 48d
Cleared Feb 15, 1979
CARTRIDGE HOLDER, RCM 100
K782175 · KIE
Waters Assoc., Inc.
Toxicology · 49d
Cleared Feb 15, 1979
SERUM, CREATININE PHOSPHOKINASE
K790015 · JHS
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 15, 1979
SERUM, GLUTAMIC-PYRUVIC
K790016 · CKA
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 15, 1979
SERUM, INORGANIC PHOSPHOROUS
K790021 · CEO
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Feb 15, 1979
DILUENT, CELLENT BLOOD
K790028 · GIF
Sysmex Corp.
Hematology · 43d
Cleared Feb 15, 1979
STAIN, HEMASTAIN RETIC
K790042 · GJH
Geometric Data, Div. Smithkline Corp.
Hematology · 41d
Cleared Feb 15, 1979
PREPARATION, DUPONT
K790110
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 29d
Cleared Feb 15, 1979
RUBANON
K790122 · GOK
Organon, Inc.
Microbiology · 23d