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
48577–48600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2011
CENTRAL MONITORING SYSTEM
K100358 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 328d
Cleared Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · EOB
Acclarent, Inc.
Ear, Nose, Throat · 311d
Cleared Jan 06, 2011
KENZ CARDY302 MAX
K101024 · MWJ
Suzuken Co., Ltd.
Cardiovascular · 268d
Cleared Jan 06, 2011
THE GRAPPLR AND GRAPPLR EXTENDER
K101616 · MBI
Tag Medical Corp.
Orthopedic · 211d
Cleared Jan 06, 2011
BD NEXIVA CLOSED IV CATHETER SYSTEM
K102520 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 126d
Cleared Jan 06, 2011
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
K102649 · BTM
Neoforce Group, Inc.
Anesthesiology · 114d
Cleared Jan 06, 2011
THE ADDITION
K102683 · MUI
Ob The-Addition, LLC
Radiology · 111d
Cleared Jan 06, 2011
NUPRO MODEL 13016901
K103160 · LBH
CAO Group, Inc.
Dental · 72d
Cleared Jan 06, 2011
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
K103168 · DRY
Sorin Group Deutschland GmbH
Cardiovascular · 71d
Cleared Jan 06, 2011
CLEARVIEW EXACT II INFLUENZA A & B TEST
K103610 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Jan 05, 2011
BIOMED WOUND CLEANSER
K100613 · FRO
Biomed Laboratories, Inc.
General & Plastic Surgery · 307d
Cleared Jan 05, 2011
MULTIFIT TOTAL HIP SYSTEM
K101472 · LZO
Otis Biotech Co., Ltd.
Orthopedic · 223d
Cleared Jan 05, 2011
GAUNYING INFRARED LAMP MODEL IL50
K101693 · ILY
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 203d
Cleared Jan 05, 2011
CALIBER SPACER
K102293 · MAX
Globus Medical, Inc.
Orthopedic · 145d
Cleared Jan 05, 2011
LTF-Y0009
K102379 · GCJ
Olympus Medical Systems Corporation
General & Plastic Surgery · 135d
Cleared Jan 05, 2011
S9 VPAP ST WITH H5I
K102513 · BZD
Resmed, Ltd.
Anesthesiology · 126d
Cleared Jan 05, 2011
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
K102544 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 124d
Cleared Jan 05, 2011
PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
K102698 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 107d
Cleared Jan 05, 2011
BUILD-IT TOTAL CORE
K102703 · EBF
Pentron Clinical
Dental · 107d
Cleared Jan 05, 2011
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS
K102806 · LCJ
Allergan Medical
General & Plastic Surgery · 99d
Cleared Jan 05, 2011
ENDOBUTTON DIRECT
K102982 · MAI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jan 05, 2011
CERETENE SOLUBLE IMPLANT MATERIAL
K103047 · KHJ
Ceremed , Inc.
Ear, Nose, Throat · 82d
Cleared Jan 05, 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · MBI
Arthrex, Inc.
Orthopedic · 79d
Cleared Jan 05, 2011
PARAMOUNT R IBF DEVICE
K103228 · MAX
Theken Spine, LLC
Orthopedic · 64d