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
74593–74616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2002
IBOND GLUMA INSIDE
K022612 · KLE
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Oct 28, 2002
ELITE MONOPHASE
K022653 · ELW
Zhermack S.P.A.
Dental · 80d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Abbott Laboratories
Chemistry · 55d
Cleared Oct 28, 2002
PQ1
K023042 · KLE
Ultradent Products, Inc.
Dental · 46d
Cleared Oct 28, 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200...
K023262 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · DQX
Guidant Corp.
Cardiovascular · 25d
Cleared Oct 28, 2002
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
K023343 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 21d
Cleared Oct 28, 2002
TRUCATH.IP
K023368 · DFG
Aortech Critical Care , Ltd.
Immunology · 20d
Cleared Oct 25, 2002
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D...
K020339 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 266d
Cleared Oct 25, 2002
DR. JAPAN FACIL POINT SPINAL NEEDLE
K020934 · BSP
Myco Medical, Inc.
Anesthesiology · 217d
Cleared Oct 25, 2002
SENSUA!
K021125 · HIS
Aac Consulting Group, Inc.
Obstetrics & Gynecology · 200d
Cleared Oct 25, 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE,...
K021186 · HIS
Condomi Erfert...
Obstetrics & Gynecology · 193d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d
Cleared Oct 25, 2002
VECTORVISION CT-FREE KNEE
K021306 · HAW
Brainlab AG
Neurology · 184d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · KWQ
Spinal Concepts, Inc.
Orthopedic · 165d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS
K021661 · KWZ
Biomet Orthopedics, Inc.
Orthopedic · 158d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS II
K021728 · KWZ
Biomet, Inc.
Orthopedic · 154d
Cleared Oct 25, 2002
GALEMED NEB-EASY NEBULIZER
K021742 · CAF
Galemed Corp.
Anesthesiology · 150d
Cleared Oct 25, 2002
DFV CPG COLPOSCOPE
K021854 · HEX
D.F. Vasconcellos S.A.
Obstetrics & Gynecology · 141d
Cleared Oct 25, 2002
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
K021976 · KQG
Vital Scientific N.V.
Hematology · 130d
Cleared Oct 25, 2002
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K022243 · KGE
Horizons Intl. Corp.
Gastroenterology & Urology · 105d
Cleared Oct 25, 2002
HORIZONS REUSABLE POLYPECTOMY SNARES
K022268 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 102d
Cleared Oct 25, 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES...
K022356 · LYR
Nichols Institute Diagnostics
Microbiology · 98d