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
71857–71880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2003
ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS
K032080 · HIL
Rostam , Ltd.
Obstetrics & Gynecology · 38d
Cleared Aug 14, 2003
XIVE DENTAL IMPLANT SYSTEM MULTIPLE
K032158 · DZE
Friadent GmbH
Dental · 30d
Cleared Aug 14, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032172 · LYZ
Synmertex Co, Ltd.
General Hospital · 29d
Cleared Aug 14, 2003
DISPOSABLE POWDERED VINYL EXAM GLOVES
K032190 · LYZ
Synmertex Co, Ltd.
General Hospital · 28d
Cleared Aug 14, 2003
XIVE TG DENTAL IMPLANT SYSTEM
K032284 · DZE
Friadent GmbH
Dental · 21d
Cleared Aug 14, 2003
ORTHOVIEW
K032401 · LLZ
Omsbar, Ltd.
Radiology · 10d
Cleared Aug 13, 2003
IVENT 201 PORTABLE VENTILATOR
K021981 · NOU
Versamed , Ltd.
Anesthesiology · 422d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 99d
Cleared Aug 13, 2003
CONDUCTION CATHETER
K031600 · FRN
Micor, Inc.
General Hospital · 84d
Cleared Aug 13, 2003
IUR FLUID MANAGEMENT SYSTEM
K031616 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 82d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651 · MQV
Curasan AG
Orthopedic · 77d
Cleared Aug 13, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE
K031865 · LON
bioMerieux, Inc.
Microbiology · 57d
Cleared Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
K032000 · GKZ
Beckman Coulter, Inc.
Hematology · 64d
Cleared Aug 13, 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 41d
Cleared Aug 13, 2003
MODIFICATION TO E-SCAN XQ
K032121 · LNH
Esaote, S.P.A.
Radiology · 35d
Cleared Aug 13, 2003
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K032246 · JSM
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Aug 13, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
K032296 · JIS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370 · DSI
Ge Medical Systems Information...
Cardiovascular · 12d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Aug 12, 2003
XIVE 3.0 DENTAL IMPLANT SYSTEM
K030639 · DZE
Friandent GmbH
Dental · 165d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · FSY
Stryker Endoscopy
General & Plastic Surgery · 130d
Cleared Aug 12, 2003
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX,...
K031106 · DZE
Imtec Corp.
Dental · 126d
Cleared Aug 12, 2003
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
K031331 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 106d
Cleared Aug 12, 2003
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K031713 · EWO
Viasys Healthcare, Inc.
Ear, Nose, Throat · 71d