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
62473–62496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 2006
ENDOSSEOUS DENTAL IMPLANT
K061169 · DZE
Northern Implants, LLC
Dental · 54d
Cleared Jun 20, 2006
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
K061324 · FED
Rtc Inc.-Memcath Technologies, LLC
Gastroenterology & Urology · 40d
Cleared Jun 20, 2006
VITEK 2 GRAM POSITIVE VRSA SCREEN
K061347 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Jun 20, 2006
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 15d
Cleared Jun 19, 2006
CUTICOVER SKIN BARRIER DEVICE
K042955 · KMF
D & D Holdings, LLC
General & Plastic Surgery · 601d
Cleared Jun 19, 2006
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
K053400 · DYB
Acumen Medical, Inc.
Cardiovascular · 195d
Cleared Jun 19, 2006
3M LIQUID BANDAGE
K053409 · KMF
3M Company
General & Plastic Surgery · 194d
Cleared Jun 19, 2006
CARTO RMT EP NAVIGATION SYSTEM V8
K060047 · DRF
Biosense Webster, Inc.
Cardiovascular · 164d
Cleared Jun 19, 2006
ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
K060431 · NYO
Mbl International Corporation
Immunology · 118d
Cleared Jun 19, 2006
MEDLINE COLLAGEN WOUND DRESSING
K060456 · KGN
Medline Industries, Inc.
General & Plastic Surgery · 117d
Cleared Jun 19, 2006
POINTER PLUS
K060508 · GZJ
Lhasa Oms, Inc.
Neurology · 112d
Cleared Jun 19, 2006
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
K060510 · JJX
Drew Scientific , Ltd.
Chemistry · 112d
Cleared Jun 19, 2006
POINTER EXCEL
K060517 · GZJ
Lhasa Oms, Inc.
Neurology · 112d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825 · LCX
Mizuho USA, Inc.
Chemistry · 84d
Cleared Jun 19, 2006
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945 · BTO
Smiths Medical International
Anesthesiology · 74d
Cleared Jun 19, 2006
US SPINE FACET FIXATION SYSTEM
K061041 · MRW
Us Spine
Orthopedic · 66d
Cleared Jun 19, 2006
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
K061203 · OWB
Ziehm Imaging, Inc.
Radiology · 49d
Cleared Jun 19, 2006
ACUTE BONE SCREW
K061206 · HWC
Acute Innovations, LLC
Orthopedic · 49d
Cleared Jun 19, 2006
INSIGHT HEAD COIL
K061281 · MOS
Insight Neuroimaging Systems, LLC
Radiology · 42d
Cleared Jun 16, 2006
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM
K051965 · HSB
Merete Medical GmbH
Orthopedic · 331d
Cleared Jun 16, 2006
EZ SMART-168 GLUCOSE MONITORING SYSTEM
K052818 · NBW
Tyson Bioresearch, Inc.
Chemistry · 255d
Cleared Jun 16, 2006
LNCS AND SPO2.COM SENSORS
K060143 · DQA
Masimo Corporation
Anesthesiology · 148d
Cleared Jun 16, 2006
SPEEDY ORTHODONTIC SCREW
K060500 · DZE
Dentium Co., Ltd.
Dental · 112d
Cleared Jun 16, 2006
IMPLANTIUM II
K060501 · DZE
Dentium Co., Ltd.
Dental · 112d