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
104761–104784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1995
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
K942276 · GIQ
Isolab, Inc.
Hematology · 255d
Cleared Jan 20, 1995
IGM RF EIA
K942908 · DHR
Sigma Diagnostics, Inc.
Immunology · 213d
Cleared Jan 20, 1995
LEKSELL SURGIPLAN
K943468 · HAW
Elekta Instruments, Inc.
Neurology · 185d
Cleared Jan 20, 1995
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505 · KGI
Hologic, Inc.
Radiology · 184d
Cleared Jan 20, 1995
ANTI-HISTONE ANIBODY TEST
K943585 · LJM
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Jan 20, 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 165d
Cleared Jan 20, 1995
CUEVA CRANIAL NERVE ELECTRODE
K944061 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 154d
Cleared Jan 20, 1995
IMAGYN MICROLAP(TM) LAPAROSCOPE
K944079 · HET
Imagyn Medical, Inc.
Obstetrics & Gynecology · 151d
Cleared Jan 20, 1995
BATTERY PACK #PMX120-18A
K945043 · IZL
Portable Power Systems, Inc.
Radiology · 98d
Cleared Jan 20, 1995
GENERA 100 SURGICAL SYSTEM
K945181 · GEX
Xintec Corporation
General & Plastic Surgery · 88d
Cleared Jan 20, 1995
HORMANN HEARING INSTRUMENTS
K945219 · ESD
Hormann, Inc.
Ear, Nose, Throat · 86d
Cleared Jan 20, 1995
JPI X-RAY GRID
K945327 · IXJ
Jpi America, Inc.
Radiology · 80d
Cleared Jan 20, 1995
JPI X-RAY FILM CASSETTE
K945328 · IXA
Jpi America, Inc.
Radiology · 80d
Cleared Jan 20, 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · KZH
Hdc Corp.
General Hospital · 73d
Cleared Jan 20, 1995
PULPDENT CANAL FINDER
K945811 · LQY
Pulpdent Corp.
Dental · 53d
Cleared Jan 20, 1995
DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT
K945831 · LRO
Micromed Development Corp.
General & Plastic Surgery · 52d
Cleared Jan 20, 1995
FUJI DUET
K946100 · EMA
GC America, Inc.
Dental · 37d
Cleared Jan 20, 1995
PULPDENT ROOT CANAL SEALER
K946138 · KIF
Pulpdent Corp.
Dental · 35d
Cleared Jan 20, 1995
SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
K946238 · FCL
Symbiosis Corp.
Gastroenterology & Urology · 29d
Cleared Jan 19, 1995
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
K934917 · ESD
Resound Corp.
Ear, Nose, Throat · 463d
Cleared Jan 19, 1995
CRIT-LINE BLOOD CHAMBER WITH E-BEAM
K935958 · KOC
In-Line Diagnostics Corp.
Gastroenterology & Urology · 419d
Cleared Jan 19, 1995
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
K940307 · JDI
Howmedica, Inc.
Orthopedic · 360d
Cleared Jan 19, 1995
S.T.E.P. UNI-KNEE
K940389 · HRY
S.T.E.P. Orthopaedics, Inc.
Orthopedic · 358d
Cleared Jan 19, 1995
DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM
K940519 · CAC
Dideco
Anesthesiology · 349d