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
73561–73584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 18, 2002
AROX 45-JBP
K023099 · DTB
Biotronik, Inc.
Cardiovascular · 30d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · DTK
Cordis Corp.
Cardiovascular · 29d
Cleared Oct 18, 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · MNH
Ebi, L.P.
Orthopedic · 23d
Cleared Oct 18, 2002
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
K023235 · LYZ
Shandong Jiazhan Plastic Products...
General Hospital · 21d
Cleared Oct 18, 2002
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K023249 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 18d
Cleared Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · HWC
Osteomed Corp.
Orthopedic · 18d
Cleared Oct 18, 2002
MICROFIX
K023314 · KTT
Fixano SA
Orthopedic · 45d
Cleared Oct 18, 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · MEB
I-Flow Corp.
General Hospital · 14d