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

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176,076 results
65929–65952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2005
MICROTEK EQUIPMENT DRAPES
K050322 · KKX
Microtek Medical, Inc.
General Hospital · 97d
Cleared May 17, 2005
PROBLOC, HN SERIES AND PROLONG, PL SERIES
K050499 · BSP
Life-Tech, Inc.
Anesthesiology · 78d
Cleared May 17, 2005
ADVANCED TURBO DRIVE SYSTEM
K050519 · GEY
Linvatec Corp.
General & Plastic Surgery · 77d
Cleared May 17, 2005
NEUROSYSTEMS 1TM MONITOR
K050702 · GWM
Neurosystems, LLC
Neurology · 60d
Cleared May 17, 2005
MODIFICATION TO: VOYAGER LINUX
K050973 · HAW
Mako Surgical Corp.
Neurology · 29d
Cleared May 17, 2005
CD HORIZON SPINAL SYSTEM
K050981 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 17, 2005
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
K051002 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 27d
Cleared May 17, 2005
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
K051096 · DYB
St. Jude Medical, Daig Division, Inc.
Cardiovascular · 18d
Cleared May 16, 2005
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
K042610 · NUP
Dr. Theiss Naturwaren GmbH
Ear, Nose, Throat · 234d
Cleared May 16, 2005
REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP,...
K043191 · FTL
Angiologica B. M. Srl
General & Plastic Surgery · 180d
Cleared May 16, 2005
POLYPROPILENE SURGICAL SUTURES
K043330 · GAW
Demetech Corp.
General & Plastic Surgery · 165d
Cleared May 16, 2005
LANX SPINAL FIXATION SYSTEM
K043484 · MNI
Lanx, LLC
Orthopedic · 150d
Cleared May 16, 2005
ARMAND ENDOSCOPE HOLDER
K050051 · GCJ
KLS-Martin L.P.
General & Plastic Surgery · 126d
Cleared May 16, 2005
DELTA HUMERAL CUPS
K050315 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 96d
Cleared May 16, 2005
TISSUE FIXATION SYSTEM
K050418 · FTL
Tfs Manufacturing Pty, Ltd.
General & Plastic Surgery · 87d
Cleared May 16, 2005
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000
K050650 · GCJ
Cytyc Surgical Products
General & Plastic Surgery · 63d
Cleared May 16, 2005
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
K050741 · JHI
Ind Diagnostic, Inc.
Chemistry · 56d
Cleared May 16, 2005
MEDIOSTAR XT
K050900 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 35d
Cleared May 16, 2005
IRMA TRUPOINT CREATININE CONTROL KIT
K050983 · JJX
International Technidyne Corporation
Chemistry · 27d
Cleared May 16, 2005
ENCOR 7 GAUGE
K051158 · KNW
Senorx, Inc.
Gastroenterology & Urology · 11d
Cleared May 15, 2005
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES,...
K050594 · LDJ
Nano-Ditech Co.
Toxicology · 68d
Cleared May 13, 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K050093 · DQK
Ge Medical Systems Information...
Cardiovascular · 119d
Cleared May 13, 2005
VITALWARE VMS
K050128 · DRG
Televital, Inc.
Cardiovascular · 114d
Cleared May 13, 2005
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
K050130 · QEZ
Kerberos Proximal Solutions, Inc.
Cardiovascular · 112d