Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82801–82824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2000
DBEST HCG 2 IU/ML TEST KIT
K001215 · JHI
Ameritek, Inc.
Chemistry · 69d
Cleared Jun 22, 2000
ORTHOCEPH OC100 D
K001439 · MUH
Instrumentarium Corp.
Radiology · 45d
Cleared Jun 22, 2000
NOVAC7
K990209 · IYE
Hitesys S.P.A.
Radiology · 518d
Cleared Jun 22, 2000
VASO PRESS DVT SYSTEM, MODELS VP500, VP501
K991038 · JOW
Britt Corp., Inc.
Cardiovascular · 451d
Cleared Jun 22, 2000
CLICKER
K994384 · KZE
Bioject, Inc.
General Hospital · 177d
Cleared Jun 22, 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · KWS
Tornier
Orthopedic · 177d
Cleared Jun 21, 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · JPA
Dade Behring, Inc.
Hematology · 79d
Cleared Jun 21, 2000
MEMOGRAPH
K001219 · JEY
Biomedical Ent., Inc.
Dental · 65d
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