FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
111337–111360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 294d
Cleared Jan 21, 1994
BIO-PREP
K931846 · LXH
Biomedical Devices, Inc.
Orthopedic · 283d
Cleared Jan 21, 1994
ALLISON MEDICAL SYRINGE
K932001 · FMF
Allison Medical, Inc.
General Hospital · 287d
Cleared Jan 21, 1994
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · ITX
Acuson Corp.
Radiology · 177d
Cleared Jan 21, 1994
FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
K934265 · DZC
Flexmedics
Dental · 143d
Cleared Jan 21, 1994
GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
K934342 · ETW
Glaser Instruments AG
Ear, Nose, Throat · 136d
Cleared Jan 21, 1994
GLASER RT60, RT80, RT150 AUDIOMETER
K934343 · EWO
Glaser Instruments AG
Ear, Nose, Throat · 136d
Cleared Jan 21, 1994
ANTIFOG
K934347 · GCJ
Norpak Mfg., Inc.
General & Plastic Surgery · 135d
Cleared Jan 21, 1994
PRECEDENT
K934405 · EMA
Reliance Orthodontic Products, Inc.
Dental · 134d
Cleared Jan 21, 1994
SONICATOR 715
K934845 · IMG
Mettler Electronics Corp.
Physical Medicine · 105d
Cleared Jan 21, 1994
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
K934901 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 99d
Cleared Jan 21, 1994
ACCU-PATH
K935250 · FCL
Cox Medical Ent., Inc.
Gastroenterology & Urology · 81d
Cleared Jan 21, 1994
NU-EAR SD-10 IN THE CANAL HEARING AID
K935326 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID
K935327 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID
K935328 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID
K935329 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID
K935330 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID
K935331 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR AE-1 IN THE EAR (ITE) HEARING AID
K935332 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-1 IN THE EAR (ITE) HEARING AID
K935333 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SD-1 IN THE EAR (ITE) HEARING AID
K935334 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID
K935335 · ESD
Nu-Ear Electronics
Ear, Nose, Throat · 77d
Cleared Jan 21, 1994
COMFORT PLUS NIPPLE SHIELDS
K935340 · HFS
Marshall Baby Products
General Hospital · 77d
Cleared Jan 21, 1994
COMFORT PLUS BREAST SHELLS
K935341 · HFS
Marshall Baby Products
General Hospital · 77d