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
169777–169800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1979
SECUTE ELBOW BAND
K791248 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX WRIST BRACE
K791249 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX KNEE BAND
K791266 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
SECUTEX ANKLE BAND
K791267 · IQI
Conphar, Inc.
Physical Medicine · 18d
Cleared Jul 24, 1979
CONPHAR OXYGEN CATHETER-STERILE
K791273 · BZB
Conphar, Inc.
Anesthesiology · 18d
Cleared Jul 24, 1979
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · DQX
Cordis Corp.
Cardiovascular · 15d
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