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
173689–173712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1977
SPINSEP-TBG
K771341 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 22d
Cleared Aug 10, 1977
LDH-INT TEST
K771343 · CFH
Hycel, Inc.
Chemistry · 21d
Cleared Aug 10, 1977
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353 · GKL
Hycel, Inc.
Hematology · 19d
Cleared Aug 10, 1977
TRANSPORTEO MODULE
K771446 · JQX
Hyland Therapeutic Div., Travenol...
Chemistry · 9d
Cleared Aug 05, 1977
RESPIRATOR, PROTABLE, VOLUME CONTROLLED
K771039 · CBK
Dept. of the Navy
Anesthesiology · 57d
Cleared Aug 04, 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
K770244 · GKZ
Abbott Laboratories
Hematology · 178d
Cleared Aug 04, 1977
PEAK FLOW METER
K770580 · BZH
Projects IN Health
Anesthesiology · 129d
Cleared Aug 04, 1977
TUBING PACK, EXTRACORPOREAL, H-3000
K770720 · BYS
William Harvey Life Products Corp.
Cardiovascular · 108d
Cleared Aug 04, 1977
TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK
K770776
Cutter Laboratories, Inc.
Cardiovascular · 98d
Cleared Aug 04, 1977
INCUBATOR, PORTABLE, ACT-STAT
K770914 · KQG
Thermolyne Corp.
Hematology · 77d
Cleared Aug 04, 1977
CARDIOZYME CK-CONTROL ABNORMAL
K770971 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
CARDIOZYME CK CONTROL NORMAL
K770973 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 65d
Cleared Aug 04, 1977
SMAC SYS., SUPPLEMENTAL PRODUCTS FOR
K771033 · CKA
Mid Tech, Inc.
Chemistry · 56d
Cleared Aug 04, 1977
HI-MID CURCUIT
K771034 · CAI
Draeger Medical, Inc.
Anesthesiology · 55d
Cleared Aug 04, 1977
NASAL OXYGEN CANNULA, #017207
K771074 · CAT
C.R. Bard, Inc.
Anesthesiology · 51d
Cleared Aug 04, 1977
OXYGEN CONNECTING TUBE #017205
K771075 · BYX
C.R. Bard, Inc.
Anesthesiology · 51d
Cleared Aug 04, 1977
DYNAZYME II Y-GT
K771084
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · CJE
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Aug 04, 1977
BLOOD GROUPING SYS., BG-9
K771098 · KSZ
Technicon Instruments Corp.
Hematology · 45d
Cleared Aug 04, 1977
VERI/CTGS MODEL 850
K771122 · GZJ
Verite Scientific, Inc.
Neurology · 43d
Cleared Aug 04, 1977
AUTO-LOGIC II SYSTEM
K771129 · JJJ
Abbott Laboratories
Chemistry · 42d
Cleared Aug 04, 1977
PIPETS UNIFORM DROP SIZE BOROSILICATE
K771137 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
PIPETS BOROSILICATE GLASS
K771138 · GJW
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 04, 1977
COPPER KETTLE VAPORIZER PLUS
K771150 · CAD
Air Products & Chemicals, Inc.
Anesthesiology · 38d