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
46513–46536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2011
MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
K110659 · MAX
Medical Concepts, Inc.
Orthopedic · 190d
Cleared Sep 13, 2011
THE UNBALLOON NON-OCCLUSIVE CATHETER
K110891 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 167d
Cleared Sep 13, 2011
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K110945 · LYZ
Zhaoyang Plastic Co., Ltd.
General Hospital · 162d
Cleared Sep 13, 2011
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
K111115 · MNI
Captiva Spine, Inc.
Orthopedic · 145d
Cleared Sep 13, 2011
REUSABLE STIMULATING ELECTRODES
K111270 · GXY
Bio Protech, Inc.
Neurology · 133d
Cleared Sep 13, 2011
SHEAUMANN PL-1064
K111359 · GEX
Sheaumann Lasers
General & Plastic Surgery · 120d
Cleared Sep 13, 2011
XELIS CARDIAC
K111660 · LLZ
Infinitt Co., Ltd.
Radiology · 91d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A&B DETECTION KIT
K111775 · OCC
U.S. Army Medical Material...
Microbiology · 82d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A SUBTYPING KIT
K111778 · OQW
U.S Army Medical Materiel Development...
Microbiology · 82d
Cleared Sep 13, 2011
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH...
K112031 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 60d
Cleared Sep 13, 2011
AMCOM COMMTECH MESSENGER
K112047 · MSX
Amcom Software,Inc.
Cardiovascular · 57d
Cleared Sep 12, 2011
WATERPAP VALVE
K110713 · BYE
Airways Development, LLC
Anesthesiology · 181d
Cleared Sep 12, 2011
JUELL HARD CURE
K111177 · EBI
Juell Dental
Dental · 138d
Cleared Sep 12, 2011
JUELL SOFT CURE
K111178 · EBI
Juell Dental
Dental · 138d
Cleared Sep 12, 2011
SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0...
K111390 · NHA
Cendres & Metaux SA
Dental · 117d
Cleared Sep 12, 2011
REKA E100
K111438 · DPS
Reka Pte, Ltd.
Cardiovascular · 111d
Cleared Sep 12, 2011
DISCOVERY
K111484 · ODP
Intuitive Spine, LLC
Orthopedic · 104d
Cleared Sep 12, 2011
STRAUMANN TIBRUSH
K111724 · ELB
Straumann USA
Dental · 84d
Cleared Sep 12, 2011
SMARTSHEARS
K112400 · FZT
Nuscience Consulting and Management...
General & Plastic Surgery · 24d
Cleared Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
K101986 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 422d
Cleared Sep 09, 2011
BIOTEQ ANGIOGRAPHIC CATHETER
K102633 · DQO
Bioteque Corp.
Cardiovascular · 361d
Cleared Sep 09, 2011
GE VEO RECONSTRUCTION OPTION
K103489 · JAK
General Electric Co.
Radiology · 287d
Cleared Sep 09, 2011
IFS PROFILE PLATES, SCREWS, AND WASHERS
K110086 · HRS
Internal Fixation Systems, Inc.
Orthopedic · 240d
Cleared Sep 09, 2011
CRYOPEN CRYOSURGICAL SYSTEM, K102214
K110754 · GEH
Cryopen, Inc.
General & Plastic Surgery · 175d