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
42289–42312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706 · CGA
Foracare, Inc.
Chemistry · 220d
Cleared Jan 14, 2013
REMESENSE FOR SENSITIVE TEETH
K122708 · LBH
Sylphar N.V.
Dental · 132d
Cleared Jan 14, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122870 · JWH
Conformis, Inc.
Orthopedic · 117d
Cleared Jan 14, 2013
QXMEDICAL ACCESS & SUPPORT CATHETER
K123311 · DQY
Qxmedical, LLC
Cardiovascular · 81d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372 · JIX
Abbott Laboratories
Chemistry · 74d
Cleared Jan 14, 2013
ACCULIF TL AND PL CAGE
K123752 · MAX
Coalign Innovations, Inc.
Orthopedic · 39d
Cleared Jan 14, 2013
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
K123898 · IYO
Volcano Corporation
Radiology · 27d
Cleared Jan 14, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905 · OQW
Centers For Disease Control and...
Microbiology · 26d
Cleared Jan 11, 2013
INFRASCANNER
K120949 · OPT
Infrascan, Inc.
Neurology · 287d
Cleared Jan 11, 2013
CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
K121254 · MAX
Camber Spine Technologies
Orthopedic · 261d
Cleared Jan 11, 2013
MTF NEW BONE VOID FILLER
K121313 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 254d
Cleared Jan 11, 2013
SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
K121765 · OLO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 210d
Cleared CT Jan 11, 2013
ICAM FUNDUS CAMERA
K122572 · HKI
Optovue, Inc.
Ophthalmic · 141d
Cleared Jan 11, 2013
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
K122576 · MJN
Stryker Neurovascular
Cardiovascular · 141d
Cleared Jan 11, 2013
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K122685 · PNO
Angioscore, Inc.
Cardiovascular · 133d
Cleared Jan 11, 2013
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K122836 · IZH
Lorad, A Hologic Co.
Radiology · 116d
Cleared Jan 11, 2013
VIVIX-S WITH VXVUE
K122866 · MQB
Vieworks Co., Ltd.
Radiology · 115d
Cleared Jan 11, 2013
HD-IVUS ULTRASOUND IMAGING SYSTEM
K122878 · OBJ
Silicon Vally Medical Instruments, Inc.
Cardiovascular · 114d
Cleared Jan 11, 2013
PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
K123048 · MHX
Advanced Instrumentations, Inc.
Cardiovascular · 105d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Jan 11, 2013
IB CLINIC
K123302 · LLZ
Imaging Biometrics, LLC
Radiology · 80d
Cleared Jan 11, 2013
SELECTRA 7F CATHETERS
K123324 · DQY
Biotronik, Inc.
Cardiovascular · 77d
Cleared Jan 11, 2013
1.5T GEM RT OPEN ARRAY
K123327 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 77d
Cleared Jan 11, 2013
SPECBOARD JR.
K123414 · IZH
Macbrud Corp., Medical Division
Radiology · 66d