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
69889–69912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2004
LABONE COCAINE METABOLITE MICRO-PLATE EIA
K040198 · DIO
Labone, Inc.
Toxicology · 36d
Cleared Mar 05, 2004
INTEGRAL HEMODIALYSIS CATHETER
K040260 · MSD
Arrow Int'L.
Gastroenterology & Urology · 30d
Cleared Mar 05, 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Mar 05, 2004
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
K040405 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 17d
Cleared Mar 05, 2004
SIMIDUR SUPERIOR
K040436 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 15d
Cleared Mar 05, 2004
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K040446 · LJS
AngioDynamics, Inc.
General Hospital · 14d
Cleared Mar 05, 2004
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
K040455 · JJX
Cliniqa Corporation
Chemistry · 11d
Cleared Mar 04, 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · KWQ
Synthes (Usa)
Orthopedic · 332d
Cleared Mar 04, 2004
SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
K032454 · DZE
Bio-Lok Intl., Inc.
Dental · 206d
Cleared Mar 04, 2004
HIOX80 AEROSOL ADAPTER
K032516 · CAF
Sensor Medics Corp.
Anesthesiology · 203d
Cleared Mar 04, 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · BZD
Respironics, Inc.
Anesthesiology · 175d
Cleared Mar 04, 2004
CALIBRATING MATERIAL, CALIBRATING STANDARDS
K033060 · JIT
Diamond Diagnostics, Inc.
Chemistry · 157d
Cleared Mar 04, 2004
IV ADMINISTRATION AND CONNECT SETS
K033301 · FPA
Codan US Corp.
General Hospital · 142d
Cleared Mar 04, 2004
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
K033842 · GCJ
Vernon-Carus Limited
General & Plastic Surgery · 85d
Cleared Mar 04, 2004
SHIRAZ POSTERIOR SYSTEM
K033947 · MNI
Spine Next America
Orthopedic · 76d
Cleared Mar 04, 2004
SHIRAZ-ANTERIOR SYSTEM
K033965 · KWQ
Spine Next America
Orthopedic · 73d
Cleared Mar 04, 2004
CONTINUM V
K040180 · EJH
Aalba Dent, Inc.
Dental · 37d
Cleared Mar 04, 2004
MESACUP-2 TEST CENP-B
K040200 · LJM
Rhigene, Inc.
Immunology · 35d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · JJY
Bio-Rad Laboratories, Inc.
Chemistry · 28d
Cleared Mar 04, 2004
PRESSURE MANIFOLD, MODEL BC 110
K040366 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 20d
Cleared Mar 04, 2004
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
K040507 · BTT
Taga Medical Technologies, Inc.
Anesthesiology · 6d
Cleared Mar 03, 2004
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
K031114 · MRB
Raven Biological Laboratories, Inc.
General Hospital · 330d
Cleared Mar 03, 2004
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
K031903 · DTZ
Guidant Corporation
Cardiovascular · 257d
Cleared Mar 03, 2004
HIGH SPEED EMG MODULE
K031930 · GWF
Medical Measurement Systems B.V.
Neurology · 254d