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
43465–43488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2012
NUVASIVE POLYAXIAL SPINAL SCREWS
K121619 · NKB
Nuvasive, Inc.
Orthopedic · 84d
Cleared Aug 24, 2012
INWAVE
K121820 · KPI
Zynex Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 24, 2012
PHANTOM PLUS CERAMIC CAGE SYSTEM
K121892 · MAX
Amedica Corp.
Orthopedic · 56d
Cleared Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
K121895 · JJX
Roche Diagnostics
Microbiology · 56d
Cleared Aug 24, 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K122254 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 28d
Cleared Aug 23, 2012
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
K111603 · DYB
Ep Dynamics, Inc.
Cardiovascular · 442d
Cleared Aug 23, 2012
FREEDOM INGUINAL HERNIA IMPLANT
K113552 · FTL
Insightra Medical
General & Plastic Surgery · 266d
Cleared Aug 23, 2012
(MULTIPLE) DIGITAL THERMOMETER
K120004 · FLL
China Shenyang Med-Land Imp/Exp...
General Hospital · 233d
Cleared Aug 23, 2012
TRANS1 INTERBODY FUSION SYSTEM
K120991 · MAX
Trans1 Incorporated
Orthopedic · 143d
Cleared Aug 23, 2012
NMI PICC III
K121089 · LJS
Navilyst Medical, Inc.
General Hospital · 135d
Cleared Aug 23, 2012
AVT NATURASOFT
K121324 · LPL
Advanced Vision Technologies
Ophthalmic · 113d
Cleared Aug 23, 2012
SYNTHES CURVILINEAR DISTRACTION SYSTEM
K121502 · MQN
Synthes, Inc.
Dental · 94d
Cleared Aug 23, 2012
AMPLATZER TORQVUE FX
K121611 · DQY
Aga Medical Corporation
Cardiovascular · 83d
Cleared Aug 23, 2012
ETCHONIA ZERONA ARMS
K121690 · OLI
Erchonia Corporation
General & Plastic Surgery · 77d
Cleared Aug 23, 2012
ERCHONIA ZERONA
K121695 · OLI
Erchonia Corporation
General & Plastic Surgery · 77d
Cleared Aug 23, 2012
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
K121824 · ELW
Lascod Spa
Dental · 63d
Cleared Aug 23, 2012
THERMAL LIGATING SHEARS
K122086 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 38d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 22, 2012
EON CALCIUM REGENT
K120626 · CJY
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry · 174d
Cleared Aug 22, 2012
PROLYTE ELECTROLYTE ANALYZER
K121140 · JGS
Diamond Diagnostics, Inc.
Chemistry · 128d
Cleared Aug 22, 2012
SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
K121181 · KNW
Alliance Partners, LLC
Gastroenterology & Urology · 126d
Cleared Aug 22, 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 126d
Cleared Aug 22, 2012
OSTEOMED CRANIAL DISTRACTION SYSTEM
K121304 · PBJ
Osteomed
Neurology · 113d
Cleared Aug 22, 2012
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
K121536 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 90d