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
37489–37512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2014
FUTURABOND M+
K141610 · KLE
Voco GmbH
Dental · 46d
Cleared Aug 01, 2014
JUSHA-C61 LCD MONITOR
K141679 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-C33C LCD MONITOR
K141684 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-M33C LCD MONITOR
K141690 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP
K141841 · MQV
Integra Lifescience Corportation
Orthopedic · 24d
Cleared Aug 01, 2014
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5...
K141859 · OZE
Centers For Disease Control and...
Microbiology · 22d
Cleared Jul 31, 2014
SILVER DENTAL ARREST
K102973 · PHR
Cooley Consulting, Inc.
Dental · 1394d
Cleared Jul 31, 2014
SYVEK RADIAL BAND
K132293 · DXC
Marine Polymer Technologies
Cardiovascular · 373d
Cleared Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
K133725 · MOF
MicroVention, Inc.
Neurology · 237d
Cleared Jul 31, 2014
S9 GREENHILLS
K140279 · BZD
Resmed, Ltd.
Anesthesiology · 178d
Cleared Jul 31, 2014
SENSILIGHT MINI
K140527 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 149d
Cleared Jul 31, 2014
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
K140603 · GEI
Saphena Medical, Inc.
General & Plastic Surgery · 143d
Cleared Jul 31, 2014
ARGEN PMMA
K140894 · EBG
The Argen Corporation
Dental · 114d
Cleared Jul 31, 2014
ENDOSIZE
K141475 · LLZ
Therenva Sas
Radiology · 57d
Cleared Jul 31, 2014
DIGIARC 100AU+
K141672 · OXO
Beijing East Whale Imaging Technology...
Radiology · 38d
Cleared Jul 31, 2014
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
K141832 · MOS
Neocoil, LLC
Radiology · 24d
Cleared Jul 30, 2014
SUCTION LIPOPLASTY ACCESSORIES
K132353 · QPB
Inex
General & Plastic Surgery · 366d
Cleared Jul 30, 2014
OXIPROBE E (OXIPROBE)
K132516 · DQA
Bio Medical Technologies Co., Ltd.
Anesthesiology · 352d
Cleared Jul 30, 2014
VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
K132709 · CAH
Vr Medical
General Hospital · 335d
Cleared Jul 30, 2014
L'DISQ
K132797 · GEI
U&I Corporation
General & Plastic Surgery · 327d
Cleared Jul 30, 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
K132912 · HWC
In2bones Sas
Orthopedic · 316d
Cleared Jul 30, 2014
ENDOLED
K133311 · NTN
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 275d
Cleared Jul 30, 2014
K2M MODULAR HOOKS
K133402 · NKB
K2m, Inc.
Orthopedic · 266d
Cleared Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
K140302 · MBH
Exactech, Inc.
Orthopedic · 174d