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
71569–71592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2003
COMPOSITE RESTORATION MATERIAL
K031721 · EBF
Milton Hodosh, M.D.
Dental · 100d
Cleared Sep 11, 2003
PANTOS, MODELS: PANTOS 16, AND PANTOS DG
K031801 · MUH
Blue X Imaging Srl
Radiology · 92d
Cleared Sep 11, 2003
QUICKVUE INFLUENZA A+B TEST
K031899 · PSZ
Quidel Corp.
Microbiology · 99d
Cleared Sep 11, 2003
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
K031951 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 79d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · MNI
Spinal Concepts, Inc.
Orthopedic · 76d
Cleared Sep 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
K032153 · LON
Bd Diagnostic Systems
Microbiology · 59d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · MBH
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared Sep 11, 2003
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE...
K032561 · GZB
Medtronic Vascular
Neurology · 22d
Cleared Sep 11, 2003
DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY
K032638 · LLZ
Planar Systems, Inc.
Radiology · 15d
Cleared Sep 11, 2003
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
K032640 · IYO
U-Systems, Inc.
Radiology · 15d
Cleared Sep 11, 2003
MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER
K032658 · FLL
Microlife Intellectual Property GmbH
General Hospital · 14d
Cleared Sep 10, 2003
PATHWAY ACCESS SHEATH CATHETER
K030734 · DYB
Vertelink Corporation
Cardiovascular · 184d
Cleared Sep 10, 2003
OSTEOMED ALVEOLAR DISTRACTION SYSTEM
K030790 · MQN
Osteomed LP
Dental · 182d
Cleared Sep 10, 2003
STERI-DRAPE SURGICAL DRAPES
K031287 · KKX
3M Company
General Hospital · 140d
Cleared Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
K031563 · DAK
The Binding Site, Ltd.
Immunology · 114d
Cleared Sep 10, 2003
UNIVERSAL NEURO SYSTEM
K031659 · JEY
Stryker Instruments
Dental · 105d
Cleared Sep 10, 2003
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW...
K031800 · FTC
Solarc Systems, Inc.
General & Plastic Surgery · 91d
Cleared Sep 10, 2003
INTERA-SENSATION FAMILY
K031815 · LNH
Philips Medical Systems
Radiology · 90d
Cleared Sep 10, 2003
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
K032134 · JZO
Kronus Market Development Associates,...
Immunology · 61d
Cleared Sep 10, 2003
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
K032271 · GEH
Wartner USA B.V.
General & Plastic Surgery · 49d
Cleared Sep 10, 2003
SIREMOBIL ISO-C 3D
K032280 · IZL
Siemens AG
Radiology · 48d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Sep 10, 2003
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · DYB
Hdc Corp.
Cardiovascular · 37d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · DHR
Roche Diagnostics Corp.
Immunology · 23d