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
58537–58560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2007
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
K071998 · FMI
Arrow Intl., Inc.
General Hospital · 65d
Cleared Sep 26, 2007
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
K072296 · KXK
Theragenics Corp.
Radiology · 40d
Cleared Sep 26, 2007
OSSIFUSE BONE SUBSTITUTE MATERIAL
K072355 · MQV
Etex Corp.
Orthopedic · 35d
Cleared Sep 26, 2007
ASAHI PTCA GUIDE WIRE, X-TREME
K072431 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 28d
Cleared Sep 26, 2007
P.004 NC GOLD ABUTMENT FOR CROWNS
K072497 · NHA
Institut Straumann AG
Dental · 21d
Cleared Sep 26, 2007
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
K072517 · IYO
Boston Scientific Corp
Radiology · 19d
Cleared Sep 25, 2007
BRAINSUITE NET
K070556 · HAW
Brainlab AG
Neurology · 210d
Cleared Sep 25, 2007
MODIFICATION TO RADIUS SNARE
K071457 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 123d
Cleared Sep 25, 2007
AVIAFIT PULSATING LEGBAND
K071744 · JOW
Flowmedic , Ltd.
Cardiovascular · 90d
Cleared Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805 · DSI
Datascope Corp.
Cardiovascular · 85d
Cleared Sep 25, 2007
CLEAR IMAGE ALIGNER
K071970 · NXC
Specialty Appliance Works, Inc.
Dental · 70d
Cleared Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
K072203 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 48d
Cleared Sep 25, 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K072392 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 25, 2007
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
K072541 · ITX
Senorx, Inc.
Radiology · 15d
Cleared Sep 25, 2007
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K072542 · FPA
Medegen Medical Manufacturing System
General Hospital · 15d
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · LJP
Diagnostic Hybrids, Inc.
Microbiology · 287d
Cleared Sep 24, 2007
GENERAL SURGERY DRAPES
K070432 · KKX
Welmed, Inc.
General Hospital · 223d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809 · LON
Becton, Dickinson & CO
Microbiology · 182d
Cleared Sep 24, 2007
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
K071346 · LIG
Immco Diagnostics, Inc.
Immunology · 133d
Cleared Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K071510 · MXJ
Focus Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 24, 2007
MARROWMINER
K071732 · GDM
Stemcor Systems, Inc.
General & Plastic Surgery · 90d
Cleared Sep 24, 2007
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K071741 · LHI
Migada Plant
General Hospital · 89d
Cleared Sep 24, 2007
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · CJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL...
K063798 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 273d