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
146593–146616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1985
BONE DENSITY CT PHANTOM
K852528 · IXG
Computerized Imaging Reference...
Radiology · 104d
Cleared Sep 26, 1985
MAXI-NEB
K852627 · CCQ
Ashai Co. , Ltd.
Anesthesiology · 98d
Cleared Sep 26, 1985
OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40
K852742 · LYC
Coors Biomedical Co.
Dental · 91d
Cleared Sep 26, 1985
TRAUMA STAND
K852952 · IYB
Xre Corp.
Radiology · 77d
Cleared Sep 26, 1985
SUPERSPIRO
K853190 · BZM
Cdx Corp.
Anesthesiology · 58d
Cleared Sep 26, 1985
SENTRY FLEXIBLE TENS
K853552 · GXY
Sentry Medical Products, Inc.
Neurology · 31d
Cleared Sep 25, 1985
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · DTN
American Bentley
Cardiovascular · 112d
Cleared Sep 25, 1985
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER
K852491 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 105d
Cleared Sep 25, 1985
CVERNE CAD DETECTOR
K852900 · DXG
Cherne Industries, Inc.
Cardiovascular · 78d
Cleared Sep 25, 1985
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
K852914 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 77d
Cleared Sep 25, 1985
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
K853100 · DYB
Cobe Laboratories, Inc.
Cardiovascular · 64d
Cleared Sep 25, 1985
HOT OR HEAT PACK
K853148 · IMD
Matrix Intl.
Physical Medicine · 58d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · JHI
Abbott Laboratories
Chemistry · 33d
Cleared Sep 25, 1985
EASY ANALYZER & EASY-TEST REAGENT
K853699 · JJE
Diagnostic Systems
Chemistry · 21d
Cleared Sep 25, 1985
APOLLO DENSITOMETER
K853734 · JQT
Astral Medical Systems
Chemistry · 19d
Cleared Sep 24, 1985
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · HQF
Visitec Co.
Ophthalmic · 102d
Cleared Sep 24, 1985
GENTLE LIFT-RECLINER CHAIR
K852864 · INO
Pride Health Care Equipment
Physical Medicine · 78d
Cleared Sep 24, 1985
HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM
K853033 · KWQ
A.W. Showell (Surgicraft) , Ltd.
Orthopedic · 68d
Cleared Sep 24, 1985
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · LZN
Dow Corning Corp. Healthcare...
Orthopedic · 56d
Cleared Sep 24, 1985
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
K853189 · HQC
Aesthetech Corp.
Ophthalmic · 56d
Cleared Sep 24, 1985
RELIANCE 1379
K853359 · HRJ
Dentsply Intl.
Ophthalmic · 43d
Cleared Sep 24, 1985
MICRON-SCOPE
K853499 · HNN
Magnum Diamond, Inc.
Ophthalmic · 35d
Cleared Sep 24, 1985
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528 · GES
Abco Dealers, Inc.
General & Plastic Surgery · 32d
Cleared Sep 24, 1985
VESSA TRAVVLA
K853593 · ITI
Vessa , Ltd.
Physical Medicine · 28d