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
156937–156960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1983
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
K823757 · BTR
Medical Engineering Corp.
Anesthesiology · 135d
Cleared Apr 28, 1983
VENTRICULAR ACCESS SYSTEM
K823790 · LKG
American Heyer Schulte
General Hospital · 133d
Cleared Apr 28, 1983
DIGIRAD CFR 2000 RADIOGRAPHIC FILM CASSETTE
K828562
Digirad Corp.
Radiology · 163d
Cleared Apr 28, 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · DQO
Mallinckrodt Critical Care
Cardiovascular · 79d
Cleared Apr 28, 1983
INFLATABLE INVALID RING
K830426 · KIC
Maddak, Inc.
Physical Medicine · 78d
Cleared Apr 28, 1983
DENTA PLAST
K830440 · EMA
Denta, Inc.
Dental · 77d
Cleared Apr 28, 1983
HEMO-PROCESSING SYSTEM
K830487 · KDI
Sartorius Filters, Inc.
Gastroenterology & Urology · 72d
Cleared Apr 28, 1983
MONITRAL
K830595 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 63d
Cleared Apr 28, 1983
PENCIL SKIN ABRADER
K830663 · DRX
Ndm Corp.
Cardiovascular · 56d
Cleared Apr 28, 1983
GLOMARK
K830703 · FZZ
Alphamedix, Inc.
General & Plastic Surgery · 52d
Cleared Apr 28, 1983
E.T. STRAP #6000
K830706 · CBH
Rnd Medical Products, Inc.
Anesthesiology · 52d
Cleared Apr 28, 1983
CARDIOVASCULAR DISPOSABLE PRODUCTS
K830728 · DWF
Electromics, Inc.
Cardiovascular · 51d
Cleared Apr 28, 1983
I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-
K830755 · FPA
Medical Parameters, Inc.
General Hospital · 49d
Cleared Apr 28, 1983
CONTRAST SENSITIVITY EQUIPMENT
K830770 · HLX
Cadwell Laboratories, Inc.
Ophthalmic · 48d
Cleared Apr 28, 1983
MARKLEY THREADED WIRE
K830773 · EBL
Almore Intl., Inc.
Dental · 48d
Cleared Apr 28, 1983
FACEBOW FOR BALANCE ARTICULATOR
K830775 · KCR
Almore Intl., Inc.
Dental · 48d
Cleared Apr 28, 1983
MICROFIL CONTOURING INSTRUMENTS
K830776 · EIY
Almore Intl., Inc.
Dental · 48d
Cleared Apr 28, 1983
LOOP RETRIEVER
K830802 · OCZ
Van-Tec, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 28, 1983
ASEPTIC FLUID TRANSFER SYSTEM
K830811 · KQQ
Steridoc Corp.
Gastroenterology & Urology · 44d
Cleared Apr 28, 1983
FRENCH PERCUTANEOUS SHEATH INTRODUCER
K830813 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 45d
Cleared Apr 28, 1983
IMPLANTABLE PACING LEAD CCS MODEL SV-101
K830828 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 43d
Cleared Apr 28, 1983
CORONARY GUIDING CATHETER
K830829 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Apr 28, 1983
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
K830843 · JKT
Rna Medical Corp.
Chemistry · 42d
Cleared Apr 28, 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · CAF
Airlife, Inc.
Anesthesiology · 38d