FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74065–74088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 18, 2002
ISO FUNCTIONAL
K022430 · ELW
GC America, Inc.
Dental · 85d
Cleared Oct 18, 2002
NIPRO BIO-FLEX CATHETER
K022756 · FOZ
Nipro Medical Corp.
General Hospital · 59d
Cleared Oct 18, 2002
TRANSCURE, MODEL 2910
K022862 · EBZ
Kinetic Instruments, Inc.
Dental · 51d
Cleared Oct 18, 2002
ELCAM STOPCOCKS AND MANIFOLDS
K022895 · FMG
Medical Device Consultants, Inc.
General Hospital · 45d
Cleared Oct 18, 2002
UNIVERSAL CERAMIC SOLDER
K022969 · EJT
Ivoclar Vivadent, Inc.
Dental · 42d
Cleared Oct 18, 2002
AQUILLA MODULAR WHEELCHAIR
K023005 · IOR
Haywood Vocational Opportunities
Physical Medicine · 39d
Cleared Oct 18, 2002
TIMEX DIGITAL ORAL THERMOMETERS
K023069 · FLL
Medport, Inc.
General Hospital · 32d
Cleared Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
K023092 · HMY
Becton, Dickinson & CO
Ophthalmic · 30d