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
146113–146136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1986
P.A. MEDICAL VAGINAL IRRIGATION SET #1130
K854595 · HED
Pa Medical Corp.
Obstetrics & Gynecology · 56d
Cleared Jan 13, 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768 · CFT
Terumo Medical Corp.
Chemistry · 47d
Cleared Jan 13, 1986
RANGE-CHEK
K854789 · JJY
American Monitor Corp.
Chemistry · 45d
Cleared Jan 13, 1986
WHITE CROSS STERILE PAD 4IN. X 4IN.
K854809
American White Cross, Inc.
General & Plastic Surgery · 41d
Cleared Jan 13, 1986
SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
K854814 · GEI
Birtcher Corp.
General & Plastic Surgery · 41d
Cleared Jan 13, 1986
LEE-BEAD BETA FSH (EIA)
K854837 · CGJ
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Jan 13, 1986
VISION CREATININE
K854846 · CGX
Abbott Laboratories
Chemistry · 40d
Cleared Jan 13, 1986
FALKON STRETCH-STERILE
K854850 · NAD
G.B.F. Industries, Inc.
General & Plastic Surgery · 40d
Cleared Jan 13, 1986
V-TREND OC CPK
K854973 · JJT
V-Tech, Inc.
Chemistry · 33d
Cleared Jan 13, 1986
CANWEST-PREGBLUE
K854989 · JHI
Canwest Medictex, Inc.
Chemistry · 32d
Cleared Jan 13, 1986
TISSUE CULTURE MEDIA
K855085 · KIT
Newport Biosystems, Inc.
Pathology · 24d
Cleared Jan 13, 1986
SUTURE REMOVAL KIT
K855131 · JOK
Dynarex Corp.
General Hospital · 21d
Cleared Jan 13, 1986
CEFACLOR SENSI-DISC
K855135 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 13, 1986
COMFORTEX WHEELCHAIR CUSHION
K855181 · KNN
Comfortex, Inc.
Physical Medicine · 18d
Cleared Jan 13, 1986
JUERGENS SELF RELIANT WHEELCHAIR
K860072 · IOR
E.H. Juergens, Inc.
Physical Medicine · 7d
Cleared Jan 10, 1986
SELECTRON HDR REMOTE AFTERLOADER
K852842 · JAQ
Nucletron-Oldelft Corp.
Radiology · 189d
Cleared Jan 10, 1986
LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
K853059 · FAP
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 175d
Cleared Jan 10, 1986
BEAMSCAN
K853671 · KPQ
Victoreen, Inc.
Radiology · 128d
Cleared Jan 10, 1986
UMS-100
K853683 · FAP
Narco Bio-Systems
Gastroenterology & Urology · 128d
Cleared Jan 10, 1986
CNS-16 & LTM 1.0 SOFTWARE
K854160 · GWS
Cns, Inc.
Neurology · 91d
Cleared Jan 10, 1986
DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS
K854204 · GXY
La Jolla Technology, Inc.
Neurology · 86d
Cleared Jan 10, 1986
ACKRAD ORAL SUCTION TUBE
K854320 · BSY
Ackrad Laboratories
Anesthesiology · 74d
Cleared Jan 10, 1986
TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
K854486 · IXR
Absolute X-Ray Corp.
Radiology · 64d
Cleared Jan 10, 1986
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K854601 · BSO
Concord Laboratories, Inc.
Anesthesiology · 53d