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
68713–68736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2004
MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS...
K041101 · EGJ
Medical Adhesiveonline, LLC
Physical Medicine · 72d
Cleared Jul 07, 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140 · FTM
Acell, Inc.
General & Plastic Surgery · 68d
Cleared Jul 07, 2004
DOVER RED RUBBER ROBINSON CATHETER
K041243 · KOD
Tyco Healthcare
Gastroenterology & Urology · 57d
Cleared Jul 07, 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · HCG
MicroVention, Inc.
Neurology · 28d
Cleared Jul 07, 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
K041582 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 23d
Cleared Jul 07, 2004
KYPHX HV-R BONE CEMENT, MODEL C01A
K041584 · NDN
Kyphon, Inc.
Orthopedic · 23d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 22d
Cleared Jul 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
K041608 · LPL
Unilens Corp., USA
Ophthalmic · 22d
Cleared Jul 06, 2004
3DKNEE POROUS COATED FEMORAL COMPONENT
K032905 · MBH
Encore Orthopedics, Inc.
Orthopedic · 293d
Cleared Jul 06, 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · JDK
Spineology, Inc.
Orthopedic · 197d
Cleared Jul 06, 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459 · JJY
Biosite Incorporated
Chemistry · 134d
Cleared Jul 06, 2004
PTS PANELS LDL CHOLESTEROL TEST STRIPS
K040693 · MRR
Polymer Technology Systems, Inc.
Chemistry · 111d
Cleared Jul 06, 2004
EBI XFIX DFS SYSTEM
K040935 · KTT
Ebi, L.P.
Orthopedic · 88d
Cleared Jul 06, 2004
MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
K041241 · FRN
Alaris Medical Systems, Inc.
General Hospital · 56d
Cleared Jul 06, 2004
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · DIF
Bio-Rad
Chemistry · 26d
Cleared Jul 06, 2004
BIS PEDIATRIC SENSOR
K041670 · GXY
Aspect Medical Systems, Inc.
Neurology · 15d
Cleared Jul 02, 2004
VARILUX VISIONPRINT SYSTEM (VPS)
K033949 · HLL
Essilor Intl.
Ophthalmic · 196d
Cleared Jul 02, 2004
SONICARE ADVANCE TOOTHBRUSH, MODEL 4900
K040416 · JEQ
Philips Oral Healthcare, Inc.
Dental · 135d
Cleared Jul 02, 2004
MYSHELL
K040498 · DTL
Sedat S.A.
Cardiovascular · 127d
Cleared Jul 02, 2004
ZILVER BILIARY STENT SYSTEM USW
K040930 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 02, 2004
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES...
K041004 · LYY
Purna Bina Sdn Bhd
General Hospital · 74d
Cleared Jul 02, 2004
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
K041043 · MOB
Pharmacia Deutschland GmbH
Immunology · 71d
Cleared Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133 · CDD
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Jul 02, 2004
DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE
K041325 · LYZ
Est International Corporation
General Hospital · 45d