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
68353–68376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2004
EXPEDIUM ANTERIOR SPINE SYSTEM
K041205 · KWQ
Depuy Spine, Inc.
Orthopedic · 102d
Cleared Aug 17, 2004
FASSIER-DUVAL TELSCOPIC IM SYSTEM
K041393 · HSB
Pega Medical, Inc.
Orthopedic · 85d
Cleared Aug 17, 2004
DC-ACETA/SAL CONTROLS
K041666 · DIF
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Aug 17, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Aug 16, 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · HWC
Inion , Ltd.
Orthopedic · 441d
Cleared Aug 16, 2004
SILVER FOAM WOUND DRESSING
K032742 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 347d
Cleared Aug 16, 2004
JMS BLOOD TUBING SETS
K032975 · FJK
Jms North America Corp.
Gastroenterology & Urology · 327d
Cleared Aug 16, 2004
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX,...
K033707 · MQV
Osteobiologics, Inc.
Orthopedic · 264d
Cleared Aug 16, 2004
EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
K033918 · HRS
Ebi, L.P.
Orthopedic · 242d
Cleared Aug 16, 2004
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
K040819 · HGM
American I.V. Products, Inc.
Obstetrics & Gynecology · 139d
Cleared Aug 16, 2004
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL...
K041194 · JJX
Medical Analysis Systems, Inc.
Chemistry · 102d
Cleared Aug 16, 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · KWQ
Nuvasive, Inc.
Orthopedic · 76d
Cleared Aug 16, 2004
KMI DISTAL VOLAR RADIUS PLATE SYSTEM
K041461 · HRS
Kinetikos Medical, Inc.
Orthopedic · 75d
Cleared Aug 16, 2004
MACRO-MICRO DEPTH ELECTRODE
K041604 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 63d
Cleared Aug 16, 2004
G5 I HBA1C TEST, G5 II HBA1C TEST
K041635 · LCP
Provalis Diagnostics , Ltd.
Chemistry · 61d
Cleared Aug 16, 2004
MICRO PRIME
K041650 · DWF
Innovx Medical, Inc.
Cardiovascular · 60d
Cleared Aug 16, 2004
SEEMOR 5.0 IMAGE DISPLAY PROGRAM
K041782 · LLZ
Areeda Assoc., Ltd.
Radiology · 46d
Cleared Aug 16, 2004
INTERLAB MICROCAL SERUM CONTROLS
K041871 · JJX
Trouble Shooter Consuling, Inc.
Chemistry · 38d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878 · NDY
Dade Behring, Inc.
Chemistry · 35d
Cleared Aug 16, 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION...
K041898 · JJX
Cliniqa Corporation
Chemistry · 33d
Cleared Aug 16, 2004
DR SYSTEMS PACS, RELEASE 6.1
K041935 · LLZ
Dr Systems, Inc.
Radiology · 28d
Cleared Aug 16, 2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · JHI
ACON Laboratories, Inc.
Chemistry · 28d
Cleared Aug 16, 2004
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
K041947 · IYO
Innovative Imaging, Inc.
Radiology · 27d
Cleared Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 25d