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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148945–148968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1985
THERAPEUTIC LIMB MANIPULATOR
K844118 · BXB
Donald E. Redding
Physical Medicine · 206d
Cleared May 17, 1985
QUINTON INJECTION SEALING CAP
K844193 · FOZ
Quinton, Inc.
General Hospital · 199d
Cleared May 17, 1985
ALCIDE REN NEW-D
K844734 · FKQ
Alcide Corp.
Gastroenterology & Urology · 164d
Cleared May 17, 1985
CURAMED 402
K850573 · IMJ
Fluidotherapy Corp.
Physical Medicine · 93d
Cleared May 17, 1985
TEMP/SC 200T -SKIN CONDUCTANCE/SKIN TEMP BIOFEEDBA
K850642 · HCC
Thought Technology , Ltd.
Neurology · 87d
Cleared May 17, 1985
HR/BVP 100T HEART RATE MONITOR
K850643 · HCC
Thought Technology , Ltd.
Neurology · 87d
Cleared May 17, 1985
WSP CODE 4310 STRESSCATH
K850694 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
WSP CODE 4300 DIOMASTER DIAGNOSTIC
K850696 · FAP
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 85d
Cleared May 17, 1985
MEDIUM FREQU. ELEC. MUSCLE STIMULATOR
K850698 · IPF
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared May 17, 1985
STERILE CORMED MEDIPORT
K850967 · LJT
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 70d
Cleared May 17, 1985
UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P
K851527 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 31d
Cleared May 17, 1985
DISPOSABLE ISOLATION GOWN
K851823 · FYC
American Threshold Industries, Inc.
General Hospital · 21d
Cleared May 17, 1985
SKYTRON ELITE 3100 SURGICAL TABLE
K851829 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 21d
Cleared May 17, 1985
SKYTRON ELITE 7000 MICRO-SURGERY TABLE
K851830 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 21d
Cleared May 17, 1985
MANAN GREENE NEEDLE
K851835 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 19d
Cleared May 17, 1985
MOLIFT
K851844 · FSA
Madshus A/S
General Hospital · 21d
Cleared May 17, 1985
BANE CURVED RONGEUR, 7 SS TYPE 420
K851882
The Huxley Instrument Corp.
General & Plastic Surgery · 18d
Cleared May 17, 1985
Y CONNECTOR
K851921 · GCD
Sil-Med Corp.
General & Plastic Surgery · 15d
Cleared May 17, 1985
HAWKIN NEEDLE
K851953 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 17, 1985
CHIBA NEEDLE
K851957 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 14d
Cleared May 16, 1985
SYNKARA
K840445 · DRX
Lectec Corp.
Cardiovascular · 472d
Cleared May 16, 1985
RECOMED BLOOD-FLOW METER H236-052-02
K840522 · DPW
Litton Medical Electronics
Cardiovascular · 464d
Cleared May 16, 1985
MODEL T 101 CLINICAL TRANSMITTER
K842435 · DXH
Biometric Products, Inc.
Cardiovascular · 330d
Cleared May 16, 1985
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356 · HQB
Coherent Medical Group
Ophthalmic · 188d