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
170977–171000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1978
OMNIPREP
K781989 · GYB
Weaver & Co.
Neurology · 18d
Cleared Dec 15, 1978
TRACH-COLLAR
K782002 · EQN
Kinetic Concepts, Inc.
Ear, Nose, Throat · 11d
Cleared Dec 15, 1978
LEAD, TIMED PACING, IMPLANTABLE
K782004 · DTB
Daig Corp.
Cardiovascular · 11d
Cleared Dec 15, 1978
MEDGENERAL SINGLE-USE BULLDOG
K782006 · GDJ
Med General
General & Plastic Surgery · 14d
Cleared Dec 15, 1978
CARDIAC CARE Q/C TEST KIT
K782033 · DRL
Instrumentation Laboratory CO
Cardiovascular · 9d
Cleared Dec 15, 1978
HEARING AID, POST-AURICULAR
K782053 · ESD
Hc Electronics
Ear, Nose, Throat · 8d
Cleared Dec 15, 1978
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · DYG
C.R. Bard, Inc.
Cardiovascular · 2d
Cleared Dec 14, 1978
AIRFLOMETER
K780894 · BZG
Glaxo Australia Ply. , Ltd.
Anesthesiology · 202d
Cleared Dec 14, 1978
STIMULATOR, MODEL 7727
K782075 · GZJ
Medtronic Vascular
Neurology · 1d
Cleared Dec 13, 1978
VENTILATOR, MINILUNG
K781160 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 161d
Cleared Dec 13, 1978
TRANSMITTER, MODEL 9406 AND 9401
K781986 · DXH
Medtronic Vascular
Cardiovascular · 19d
Cleared Dec 13, 1978
SPIROCARE 108-B
K782016 · BWF
Marion Laboratories, Inc.
Anesthesiology · 8d
Cleared Dec 12, 1978
VENTILATOR, PRESSURE
K781159 · CBK
Thompson Respiration Products, Inc.
Anesthesiology · 160d
Cleared Dec 12, 1978
MODEL IV 1500 STANDARD BURETTE
K781637 · FPA
Valleylab, Inc.
General Hospital · 82d
Cleared Dec 12, 1978
DEFIBRILLATOR, MARK II
K781678 · LDD
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 12, 1978
MONITOR/MINI SCOPE
K781679 · DPS
Ipco Corp.
Cardiovascular · 71d
Cleared Dec 12, 1978
ADAPTER, C/D SUCTION
K781713 · BTR
Novametrix Medical Systems, Inc.
Anesthesiology · 67d
Cleared Dec 12, 1978
IRRIGATION TRAY
K781748 · EYN
Intermed, Inc.
General & Plastic Surgery · 56d
Cleared Dec 12, 1978
ADAPTER, CATHETER SHEATH
K781846 · KGZ
Arrow Intl., Inc.
General & Plastic Surgery · 41d
Cleared Dec 12, 1978
9100 DAYSTAR AND 9110 ORBITER PACKAGE
K781887 · FSY
Castle Co.
General & Plastic Surgery · 35d
Cleared Dec 12, 1978
COMPRESSION DEVICES, LIMB
K781964 · IRP
Alba-Waldensian, Inc.
Physical Medicine · 22d
Cleared Dec 12, 1978
PUNCTURE KIT, DISPOSALBE VEIN
K781978 · FMF
Arrow Intl., Inc.
General Hospital · 15d
Cleared Dec 12, 1978
SUCTION APPARATUS, POWERED BY COMP. AIR
K781988 · GCX
Farley, W.T.
General Hospital · 15d
Cleared Dec 12, 1978
FLAT SILICONE DRAIN
K782026 · GCY
Davol, Inc.
General & Plastic Surgery · 7d