FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82201–82224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2000
SERAGARD INJECTION PATCH
K001240 · KGX
Platinum Services, Inc.
General & Plastic Surgery · 64d
Cleared Jun 21, 2000
DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
K001269 · EJH
Dentalmatic Technologies, Inc.
Dental · 62d
Cleared Jun 21, 2000
PALCERAM 53
K001479 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
AURECAST 40 B
K001480 · EJT
Aurex SA (Pty) , Ltd.
Dental · 41d
Cleared Jun 21, 2000
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K001629 · FRN
Disetronic Medical Systems AG
General Hospital · 26d
Cleared Jun 21, 2000
MILLENNIA ACUPUNCTURE NEEDLE
K001718 · MQX
United Pacific Co., Ltd.
General Hospital · 16d
Cleared Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · CGX
Ortho-Clinical Diagnostics
Chemistry · 9d
Cleared Jun 21, 2000
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
K001786 · DZE
Sulzer Calcitek, Inc.
Dental · 8d
Cleared Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · HLI
Canon USA, Inc.
Ophthalmic · 323d
Cleared Jun 21, 2000
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · LDJ
Alfa Scientific Designs, Inc.
Toxicology · 176d
Cleared Jun 20, 2000
3D-MSPECT
K001026 · KPS
The Reagents of the University of...
Radiology · 82d
Cleared Jun 20, 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · JPA
Dade Behring, Inc.
Hematology · 78d
Cleared Jun 20, 2000
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
K001286 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Jun 20, 2000
BREAST IMMOBILIZATION DEVICE MR-BY 160
K001303 · MOS
Mri Devices Corp.
Radiology · 57d
Cleared Jun 20, 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Jun 20, 2000
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
K001312 · MOS
Igc-Medical Advances, Inc.
Radiology · 55d
Cleared Jun 20, 2000
SIGNUM
K001360 · EBF
J.F. Jelenko & Co., Inc.
Dental · 53d
Cleared Jun 20, 2000
AURELUX Y 84 PREMIUM
K001477 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
AURECAST SUPER INLAY
K001478 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559 · MQV
Howmedica Osteonics Corp.
Orthopedic · 32d
Cleared Jun 20, 2000
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
K001711 · IYN
Agilent Technologies, Inc.
Radiology · 15d
Cleared Jun 20, 2000
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL...
K001733 · JDI
Zimmer, Inc.
Orthopedic · 13d
Cleared Jun 20, 2000
MEDI-CULT M3 MEDIUM
K991331 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d
Cleared Jun 20, 2000
MEDI-CULT HYALURONIDASE
K991334 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d