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
59617–59640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2007
MODIFICATION TO FLOWSCREEN
K062011 · BTY
Viasys Healthcare GmbH
Anesthesiology · 298d
Cleared May 11, 2007
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
K062572 · MQN
Custom Scientific
Dental · 253d
Cleared May 11, 2007
ACCUPULSE PULSE OXIMETER
K062724 · DQA
Eagle Medical Equipment Co.
Anesthesiology · 241d
Cleared May 11, 2007
RTR SYRINGE
K063634 · LYC
Septodont
Dental · 156d
Cleared May 11, 2007
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
K063638 · DQY
St Jude Medical
Cardiovascular · 155d
Cleared May 11, 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693 · KHE
New Bay Bioresearch Co. , Ltd.
Hematology · 149d
Cleared May 11, 2007
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K070313 · LFL
Misonix, Inc.
General & Plastic Surgery · 99d
Cleared May 11, 2007
SKIPPI POWERED WHEELCHAIR FOR CHILDREN
K070318 · ITI
Otto Bock Healthcare LP
Physical Medicine · 98d
Cleared May 11, 2007
ALLOFIX PUSH-IN ANCHOR
K070347 · HWC
Musculoskeletal Transplant Foundation
Orthopedic · 94d
Cleared May 11, 2007
FETCH ASPIRATION CATHETER
K070363 · QEZ
Possis Medical, Inc.
Cardiovascular · 93d
Cleared May 11, 2007
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST,...
K070591 · ELM
Union Dental S.A./Unidesa.Odi
Dental · 71d
Cleared May 11, 2007
ADHESE ONE
K070646 · KLE
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared May 11, 2007
COLORISE
K070677 · ELW
Zhermack S.P.A.
Dental · 60d
Cleared May 11, 2007
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
K070860 · LON
Dade Behring, Inc.
Microbiology · 44d
Cleared May 11, 2007
DURACON X3 CS TIBIAL INSERT
K070883 · MBH
Howmedica Osteonics Corp.
Orthopedic · 42d
Cleared May 11, 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · GJS
Roche Diagnostics
Hematology · 29d
Cleared May 11, 2007
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
K071073 · MHX
Ge Medical Systems Information...
Cardiovascular · 25d
Cleared May 11, 2007
ASNIS MICRO CANNULATED SCREW
K071092 · HWC
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared May 10, 2007
WN SYNOCTA GOLD ABUTMENT
K063789 · NHA
Straumann USA
Dental · 140d
Cleared May 10, 2007
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
K070086 · DXN
Sensacare , Ltd.
Cardiovascular · 121d
Cleared May 10, 2007
FUSION RESIN CEMENT AND CORE KIT
K070702 · EBF
Denali Corporation
Dental · 58d
Cleared May 10, 2007
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200...
K070821 · LYY
Medtexx Manufacturing Sdn. Bhd.
General Hospital · 45d
Cleared May 10, 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 10, 2007
SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
K071037 · IZI
Novadaq Technologies, Inc.
Radiology · 28d