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
44905–44928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2012
CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER...
K113766 · JAQ
Varian Medical Systems, Inc.
Radiology · 86d
Cleared Mar 16, 2012
DEFLEX ACRILATO
K113788 · EBI
Nuxen S.R.L.
Dental · 85d
Cleared Mar 16, 2012
V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
K113811 · DQK
C.R. Bard Inc., Bard...
Cardiovascular · 84d
Cleared Mar 16, 2012
CHESAPEAKE SPINAL SYSTEM
K120031 · OVD
K2m, Inc.
Orthopedic · 72d
Cleared Mar 16, 2012
E-CUBE 9
K120060 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 67d
Cleared Mar 16, 2012
ELECTROCARDIOGRAPH
K120188 · DPS
Edan Instruments, Inc.
Cardiovascular · 53d
Cleared Mar 16, 2012
INSORB ABSORBALBE STAPLE
K120373 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 39d
Cleared Mar 16, 2012
GORE(R) EMBOLIC FILTER
K120480 · NTE
W.L. Gore & Associates
Cardiovascular · 29d
Cleared Mar 16, 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND...
K120485 · OMA
Nihon Kohden America, Inc.
Neurology · 28d
Cleared CT Mar 15, 2012
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933 · BZQ
Covidien
Anesthesiology · 251d
Cleared Mar 15, 2012
CAREFUSION NICOLET EDX
K112052 · GWF
Carefusion 209, Inc.
Neurology · 241d
Cleared Mar 15, 2012
CONCENTRIC BALLOON GUIDE CATHETER
K112404 · DQY
Concentric Medical, Inc.
Cardiovascular · 206d
Cleared Mar 15, 2012
AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
K112998 · DRM
Zoll Circulation
Cardiovascular · 160d
Cleared Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · GEI
Boston Scientific Corporation
General & Plastic Surgery · 148d
Cleared Mar 15, 2012
CITIEFFE TITANIUM NAILING SYSTEM
K113387 · HSB
Citieffe
Orthopedic · 120d
Cleared Mar 15, 2012
IM-11 PNEUMATIC MICROINJECTOR
K113712 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 87d
Cleared Mar 15, 2012
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
K113749 · LYZ
Full Synergy Medical Products, Inc.
General Hospital · 85d
Cleared Mar 15, 2012
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · OZE
Quidel Corp.
Microbiology · 85d
Cleared Mar 15, 2012
B-GENIN, R-GENIN
K113791 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 84d
Cleared Mar 15, 2012
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH...
K120120 · DQY
Aga Medical Corporation
Cardiovascular · 58d
Cleared Mar 15, 2012
ENDOSCOPIC APPLICATOR
K120608 · GCJ
Micromedics, Inc.
General & Plastic Surgery · 15d
Cleared Mar 15, 2012
CONQUEST 40 PTA DILATATION CATHETER
K120660 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 10d
Cleared Mar 15, 2012
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
K120677 · LIT
Trireme Medical, Inc.
Cardiovascular · 9d
Cleared Mar 14, 2012
POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
K102189 · LZC
Latexx Manufacturing Sdn.Bhd.
General Hospital · 590d