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
94825–94848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1997
AUDIOTONE (A-552)
K965063 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
K965072 · EHD
Kaycor Intl., Ltd.
Radiology · 39d
Cleared Jan 27, 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K965096 · IXR
U.S. Imaging Tables, Inc.
Radiology · 38d
Cleared Jan 27, 1997
KODAK MINILOADER(2000)
K970059 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Jan 24, 1997
FINN ROD TO ROD CONNECTOR
K960444 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 358d
Cleared Jan 24, 1997
MEDTEXX
K963331 · LYY
Regalfield Sdn. Bhd.
General Hospital · 154d
Cleared Jan 24, 1997
MICRO H2
K963376 · NRH
Micro Direct, Inc.
Chemistry · 150d
Cleared Jan 24, 1997
WHEELCHAIR BELT
K963479 · KID
Deroyal Industries, Inc.
Physical Medicine · 143d
Cleared Jan 24, 1997
FERR FLEX REAGENT CARTRIDGE
K963498 · JMG
Dade Chemistry Systems, Inc.
Chemistry · 143d
Cleared Jan 24, 1997
SOMA SAFE ENCLOSURE
K963701 · FNL
Nova Technology Corp.
General Hospital · 130d
Cleared Jan 24, 1997
FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES
K964317 · LYY
Nantong Ruchang Latex Products Co., Ltd.
General Hospital · 87d
Cleared Jan 24, 1997
AXIOM INF
K964423 · IPF
Axiom Manufacturing
Physical Medicine · 112d
Cleared Jan 24, 1997
THE ROBOLITE
K964460 · JQP
Shai Syg Motion and Innovations, Ltd.
Radiology · 78d
Cleared Jan 24, 1997
FLEXIBLE URETEROSCOPE
K964482 · FGB
Applied Fiberoptics, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 24, 1997
KARTUSH TM PATCHER
K964484 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 78d
Cleared Jan 24, 1997
TAP
K964516 · LRK
Nellcor Puritan Bennett, Inc.
Dental · 80d
Cleared Jan 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
K964531 · LNH
Us Asia Instruments, Inc.
Radiology · 73d
Cleared Jan 24, 1997
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K964537 · GXP
Osteogenics, Inc.
Neurology · 73d
Cleared Jan 24, 1997
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL...
K964577 · KPI
Empi
Gastroenterology & Urology · 71d
Cleared Jan 24, 1997
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
K964649 · JEY
Howmedica Leibinger, Inc.
Dental · 65d
Cleared Jan 24, 1997
COMFORTAID HEARING AID
K964680 · ESD
Ethical Hearing Instruments
Ear, Nose, Throat · 63d
Cleared Jan 24, 1997
ELECSYS LH ASSAY
K964694 · CEP
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · LZO
Depuy, Inc.
Orthopedic · 60d
Cleared Jan 24, 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746 · JAK
GE Medical Systems
Radiology · 59d