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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123313–123336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1990
OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH
K902295 · LYC
Ceramed Corp.
Dental · 203d
Cleared Dec 11, 1990
INTERVERTEBRAL DISC RONGEUR
K903151 · HAE
Von Zeppelin GmbH
Neurology · 146d
Cleared Dec 11, 1990
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
K904004 · CGS
Amresco, Inc.
Chemistry · 104d
Cleared Dec 11, 1990
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
K904209 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 90d
Cleared Dec 11, 1990
QUICKANCHOR (TM)
K904436 · GAS
Mitek Surgical Products, Inc.
General & Plastic Surgery · 74d
Cleared Dec 11, 1990
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS
K904905 · DIF
Medical Analysis Systems, Inc.
Chemistry · 42d
Cleared Dec 11, 1990
DISPOSABLE SURGICAL TOWEL (NON-STERILE)
K905005 · KKX
Marand Products, Inc.
General Hospital · 34d
Cleared Dec 11, 1990
REMOTE CONTROLLED X-RAY DIAG. RSZ-200
K905152 · IXR
Shimadzu Medical Systems
Radiology · 26d
Cleared Dec 11, 1990
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110
K905153 · IXR
Shimadzu Medical Systems
Radiology · 26d
Cleared Dec 11, 1990
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL
K905226 · JGY
Enzyme Technology, Inc.
Chemistry · 21d
Cleared Dec 11, 1990
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · LBR
Amresco, Inc.
Chemistry · 18d
Cleared Dec 11, 1990
THOMPSON TYPE HIP PROSTHESIS
K905334 · KWL
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
STEINMAN PIN, THREADED
K905336 · JDW
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
STEINMAN PIN
K905337 · HTY
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
SIDE PLATE
K905338 · KTT
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
RUSH PIN
K905341 · HTY
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
LAG SCREW
K905342 · KTT
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
KNOWLES PIN
K905344 · JDW
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
K-WIRE
K905345 · HTY
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
JEWETT HIP NAIL
K905346 · KTT
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
HANSEN-STREET TYPE INTRAMEDULLARY NAIL
K905348 · KTW
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
AUSTIN MOORE TYPE HIP PROTHESIS
K905349 · KWL
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
BLADE PLATE
K905352 · KTT
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
BARBED SQUARE STAPLE
K905362 · JDR
O'Tec Corp.
Orthopedic · 13d