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
168937–168960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1979
OPERATION MICROSCOPE SOM 1
K791280 · FSO
Elmed, Inc.
General & Plastic Surgery · 14d
Cleared Jul 24, 1979
WECK MICROSURGICAL KNIFE
K791286 · EMF
Vista Medical Products, Inc.
General & Plastic Surgery · 15d
Cleared Jul 24, 1979
GIZMO TOWEL CLAMP
K791289 · HXD
Hemoy, Inc.
General & Plastic Surgery · 14d
Cleared Jul 17, 1979
CONCEPT II
K790339 · EBE
Richardson Merrel, Inc.
Dental · 146d
Cleared Jul 17, 1979
LIPASE REAGENT SET
K790796 · CET
Alta Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 17, 1979
AMYLASE REAGENT SET
K790797 · KHM
Alta Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 17, 1979
HEMATRAK MODEL 480
K790816 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 81d
Cleared Jul 17, 1979
HUMAN CHORIONIC GONADOTROPHIN STANDARDS
K790863 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
RABBIT ANTISERUM TO HUMAN CHORIONIC
K790864 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876 · JHI
Pcl-Ria, Inc.
Chemistry · 71d
Cleared Jul 17, 1979
P.A.P. RIA CONTROL SERUM PACK
K790985 · JJT
Mallinckrodt Critical Care
Chemistry · 53d
Cleared Jul 17, 1979
FERMCOTEST R BUN RATE REAGENT TEST KIT
K791018 · CDS
Fermco Biochemics, Inc.
Chemistry · 46d
Cleared Jul 17, 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · JJX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jul 17, 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031 · JJX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jul 17, 1979
POPE OTO-WICK, STERILE & NON-STERILE
K791059 · KCN
Xomed, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 17, 1979
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079 · CGN
Clinical Assays, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF LDH-
K791081 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM REAGENT, DETERMINATION OF AST
K791082 · CIT
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084 · CKA
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
PLUS CHEM, DETERMINATION OF LD (LDH-P)
K791085 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 17, 1979
CARY 210 SERIES, SPECTROPHOTOMETER
K791102 · JJQ
Varian Assoc., Inc.
Chemistry · 34d
Cleared Jul 17, 1979
CONTEXT FILTER
K791108 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 33d
Cleared Jul 17, 1979
MODEL CE-DM-II HEARING INSTRUMENT
K791126 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 29d