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
102097–102120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1995
ACURA-EX
K946232 · ESD
Lustgarten Multi-Tech Intl.
Ear, Nose, Throat · 190d
Cleared Jun 30, 1995
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
K950196 · JTY
Bioclinical Systems, Inc.
Microbiology · 163d
Cleared Jun 30, 1995
MEDIPACS
K950413 · LMD
Nexsys Electronics
Radiology · 150d
Cleared Jun 30, 1995
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
K950533 · EAP
Trophy Radiologie
Radiology · 147d
Cleared Jun 30, 1995
K4 BONE SCREW SYSTEM
K950704 · HWC
Kinetikos Medical, Inc.
Orthopedic · 135d
Cleared Jun 30, 1995
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
K950730 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 134d
Cleared Jun 30, 1995
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
K950820 · BSP
Spinal Specialties, Inc.
Anesthesiology · 127d
Cleared Jun 30, 1995
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)
K951175 · LMD
Sirius Corp.
Radiology · 107d
Cleared Jun 30, 1995
COMBINATION CAMERA/LIGHT SOURCE
K951386 · GCJ
M.P. Video, Inc.
General & Plastic Surgery · 95d
Cleared Jun 30, 1995
FLEX D-4000
K951419 · INQ
U.S. Table, Inc.
Physical Medicine · 94d
Cleared Jun 30, 1995
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · JZO
Shield Diagnostics, Ltd.
Immunology · 91d
Cleared Jun 30, 1995
HYDRAGEL PROTEIN(E) KIT
K951536 · CEF
Sebia
Chemistry · 88d
Cleared Jun 30, 1995
3I ASYST ABUTMENT PACKAGE SYSTEM
K951553 · DZE
Implant Innovations, Inc.
Dental · 87d
Cleared Jun 30, 1995
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K
K951587 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 85d
Cleared Jun 30, 1995
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT
K951828 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Jun 30, 1995
LOK-ON NEEDLE DISPOSAL SYSTEM
K951886 · GIM
Becton Dickinson Vacutainer Systems
Chemistry · 67d
Cleared Jun 30, 1995
ZIRCONIA ARTICUL/EZE FEMORAL BALLS
K952088 · LZO
Depuy, Inc.
Orthopedic · 58d
Cleared Jun 30, 1995
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
K952165 · HQD
Rand Scientific Corp.
Ophthalmic · 88d
Cleared Jun 30, 1995
DIASTAT ANTI-THYROGLOBULIN KIT
K952183 · JZO
Shield Diagnostics, Ltd.
Immunology · 52d
Cleared Jun 30, 1995
MPM HYDROGEL DRESSING
K952276 · MGQ
Mpm Medical., Inc.
General & Plastic Surgery · 46d
Cleared Jun 30, 1995
ENDO PROSTHESIS FEMORAL HEAD
K952461 · JDI
Stelkast Company
Orthopedic · 35d
Cleared Jun 29, 1995
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
K933934 · JBF
Sigma Diagnostics, Inc.
Hematology · 687d
Cleared Jun 29, 1995
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · EZL
Baxter Healthcare Corp
Gastroenterology & Urology · 317d
Cleared Jun 29, 1995
ENDO-BEND(TM) SHAVER
K950054 · HRX
Paladin Medical, Inc.
Orthopedic · 174d