FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73537–73560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332 · JAK
GE Medical Systems
Radiology · 16d
Cleared Oct 22, 2002
SMITHWICK CAROTID SHUNT
K021608 · DXC
Implantable Devices
Cardiovascular · 159d
Cleared Oct 22, 2002
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
K022420 · HCG
Micrus Corp.
Neurology · 90d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED...
K022450 · DTZ
Dideco S.P.A.
Cardiovascular · 88d
Cleared Oct 22, 2002
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
K022535 · EFB
Microtech
Dental · 83d
Cleared Oct 22, 2002
EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
K022582 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Oct 22, 2002
HCMI X-RAY
K022667 · KPR
Health Care Mfg., Inc.
Radiology · 71d
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