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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
42745–42768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2012
VICEROY SPINAL SYSTEM
K122229 · NKB
Torrey Spine
Orthopedic · 117d
Cleared Nov 20, 2012
UFIT TEN-10
K122443 · DXN
Biosign Technologies, Inc.
Cardiovascular · 102d
Cleared Nov 20, 2012
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 99d
Cleared Nov 20, 2012
3M TRUE DEFINITION SCANNER
K122467 · NOF
3M Company
Dental · 99d
Cleared Nov 20, 2012
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
K122488 · DXX
Catheter Robotics, Inc.
Cardiovascular · 97d
Cleared Nov 20, 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573 · DQX
Abbott Vascular, Inc.
Cardiovascular · 89d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Nov 20, 2012
PHT-6500
K122606 · OAS
Mtechgroup
Radiology · 85d
Cleared Nov 20, 2012
PENUMBRA DDC CATHETERS
K122772 · DQY
Penumbra, Inc.
Cardiovascular · 71d
Cleared Nov 20, 2012
S-LOK PSS SYSTEM
K122931 · MNI
Spinal USA
Orthopedic · 57d
Cleared Nov 20, 2012
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K123039 · DRY
Terumo Cardiovascular Systems Corp.
Cardiovascular · 53d
Cleared Nov 20, 2012
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK...
K123198 · JJY
Bio-Rad Laboratories
Chemistry · 40d
Cleared Nov 20, 2012
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229 · DRG
Intouch Health, Inc.
Cardiovascular · 36d
Cleared Nov 20, 2012
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K123297 · MBF
Biomet Manufactuting Corp.
Orthopedic · 29d
Cleared Nov 20, 2012
SYNGO.VIA
K123375 · LLZ
Siemens AG
Radiology · 19d
Cleared Nov 20, 2012
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K123409 · GAM
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 15d
Cleared Nov 19, 2012
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K113567 · JEY
Synthes, Inc.
Dental · 353d
Cleared Nov 19, 2012
PTFE SUPER SHEATH INTRODUCER
K120617 · DYB
Martech Medical Products
Cardiovascular · 264d
Cleared Nov 19, 2012
NON-CONTACT THERMOMETER
K120711 · FLL
K-Jump Health Co., Ltd.
General Hospital · 256d
Cleared Nov 19, 2012
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
K121100 · LON
bioMerieux, Inc.
Microbiology · 222d
Cleared Nov 19, 2012
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ...
K121494 · HRS
Aap Implantate AG
Orthopedic · 182d
Cleared Nov 19, 2012
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791 · KWQ
Corelink, LLC
Orthopedic · 153d
Cleared Nov 19, 2012
MOBILECARE MONITOR
K122333 · DRG
Aframe Digital, Inc.
Cardiovascular · 109d
Cleared Nov 19, 2012
ALIVECOR HEART MONITOR FOR IPHONE
K122356 · DPS
AliveCor, Inc.
Cardiovascular · 108d