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
95329–95352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395 · LZO
Hayes Medical, Inc.
Orthopedic · 84d
Cleared Jan 27, 1997
LR 5200 LASER FILM RECORDER
K964414 · LMC
Bayer Corp., Agfa Div.
Radiology · 83d
Cleared Jan 27, 1997
AQUABOND ELECTRODE
K964433 · GXY
Medibond , Ltd.
Neurology · 83d
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675 · LYR
Pyramid Biological Corp.
Microbiology · 67d
Cleared Jan 27, 1997
DYNAMOMETER
K964685 · LBB
John Chatillon & Sons, Inc.
Neurology · 66d
Cleared Jan 27, 1997
S.A.M. FACIAL IMPLANT W/INTRODUCER
K964761 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Jan 27, 1997
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048 · JJY
Johnson & Johnson Clinical...
Chemistry · 40d
Cleared Jan 27, 1997
DAHLBERG (A-554)
K965049 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A554H)
K965057 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
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