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

Filters: Cleared only ×
176,076 results
74665–74688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2002
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K022737 · KPR
Health Care Mfg., Inc.
Radiology · 64d
Cleared Oct 22, 2002
CEDARA I-SOFTVIEW
K022881 · LLZ
Cedara Software Corp.
Radiology · 53d
Cleared Oct 22, 2002
BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
K023055 · DXN
Vsm Medtech , Ltd.
Cardiovascular · 39d
Cleared Oct 22, 2002
USG 2000SA
K023227 · HHJ
Ultraguide , Ltd.
Radiology · 25d
Cleared Oct 22, 2002
DRYSTAR 5500
K023287 · LMC
Agfa Corp.
Radiology · 20d
Cleared Oct 21, 2002
DIASOL-ADDITIVES
K020231 · KPO
Diasol, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 21, 2002
56 SERIES JET NEBULIZER
K021443 · CAF
Project Marketing
Anesthesiology · 168d
Cleared Oct 21, 2002
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
K022391 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 21, 2002
IQ 200 SYSTEM
K022774 · LKM
Intl. Remote Imaging Systems
Pathology · 61d
Cleared Oct 21, 2002
ANSPACH POWERED KERRISON SYSTEM (PKS)
K022907 · HAD
The Anspach Effort, Inc.
Neurology · 48d
Cleared Oct 21, 2002
NXSTAGE PREMIXED DIALYSATE
K022913 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Oct 21, 2002
CRANIOCUT
K022942 · HBE
Aesculap, Inc.
Neurology · 46d
Cleared Oct 21, 2002
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER...
K022987 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 42d
Cleared Oct 21, 2002
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
K023245 · NJJ
Paradigm Medical Industries, Inc.
Ophthalmic · 21d
Cleared Oct 18, 2002
COMPAS
K021200 · BZG
Morgan Scientific, Inc.
Anesthesiology · 185d
Cleared Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451 · JWH
Howmedica Osteonics Corp.
Orthopedic · 165d
Cleared Oct 18, 2002
NICALERT
K021688 · MRS
Nymox Pharmaceutical Corporation
Toxicology · 149d
Cleared Oct 18, 2002
SMART PLUG, MODEL 500
K022043 · LZU
Medennium, Inc.
Ophthalmic · 116d
Cleared Oct 18, 2002
VKS KNEE SYSTEM
K022204 · JWH
Plus Orthopedics
Orthopedic · 105d
Cleared Oct 18, 2002
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER...
K022346 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 91d
Cleared Oct 18, 2002
FRAMELOCK
K022370 · HBG
Medtronic Xomed, Inc.
Neurology · 88d
Cleared Oct 18, 2002
PLASMALITE PULSED LIGHT SYSTEM
K022378 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 88d
Cleared Oct 18, 2002
PROFILE 1320 LASER SYSTEM
K022381 · GEX
Sciton, Inc
General & Plastic Surgery · 88d
Cleared Oct 18, 2002
XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
K022384 · HET
Isolux America
Obstetrics & Gynecology · 88d