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
37969–37992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2014
CHESAPEAKE SPINAL SYSTEM
K133494 · OVD
K2m, Inc.
Orthopedic · 208d
Cleared Jun 10, 2014
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
K133770 · GAT
Anchor Innovation Medical (A.I.M.)
General & Plastic Surgery · 181d
Cleared Jun 10, 2014
ESTEMP IMPLANT, ESTEMP CLEAR
K134021 · EMA
Spident Co., Ltd.
Dental · 162d
Cleared Jun 10, 2014
HEARTNAVIGATOR RELEASE 2.0
K140138 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 139d
Cleared Jun 10, 2014
ORTHALIGN PLUS SYSTEM
K140331 · OLO
Orthalign, Inc.
Orthopedic · 120d
Cleared Jun 10, 2014
MASTERGRAFT PUTTY
K140374 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 116d
Cleared Jun 10, 2014
TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH
K140521 · GEI
ArthroCare Corporation
General & Plastic Surgery · 98d
Cleared Jun 10, 2014
PCD 737A
K140642 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 90d
Cleared Jun 10, 2014
EMERGE EXTERNAL FIXATION SYSTEM
K140675 · KTT
Emerge Medical, Inc.
Orthopedic · 84d
Cleared Jun 10, 2014
FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK
K140967 · FTL
Insightra Medical
General & Plastic Surgery · 57d
Cleared Jun 10, 2014
MASTERSL FEMORAL STEM
K140975 · LZO
Lima Corporate S.P.A.
Orthopedic · 55d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · JWY
Thermo Fisher Scientific
Microbiology · 55d
Cleared Jun 10, 2014
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 10, 2014
GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON...
K141259 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 26d
Cleared Jun 09, 2014
ECLERIS SINUSCOPE
K131323 · EOB
Ecleris USA
Ear, Nose, Throat · 397d
Cleared Jun 09, 2014
AIRSOFT F15
K132901 · BZD
Resmed, Ltd.
Anesthesiology · 266d
Cleared Jun 09, 2014
SENTIERO
K133012 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 09, 2014
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
K140357 · HRS
Orthopaedic Implant Company
Orthopedic · 117d
Cleared Jun 09, 2014
AERO BLUE PERFORMANCE SURGICAL GOWN
K140539 · FYA
Kimberly Clark Corporation
General Hospital · 97d
Cleared Jun 09, 2014
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K140930 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 59d
Cleared Jun 09, 2014
GUARDIAN URETHRAL SHEATH
K141252 · KNY
Solace Therapeutics
Gastroenterology & Urology · 26d
Cleared Jun 06, 2014
HANDHELD MONITOR
K131762 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 354d
Cleared Jun 06, 2014
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
K132205 · CAW
Inova Labs, Inc.
Anesthesiology · 325d
Cleared Jun 06, 2014
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
K132415 · BTR
Teleflexmedical, Inc.
Anesthesiology · 308d