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
37465–37488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2014
CLOSURERFG RADIOFREQUENCY GENERATOR
K141858 · GEI
Covidien
General & Plastic Surgery · 26d
Cleared Aug 04, 2014
GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
K131230 · NBW
Philosys, Inc.
Chemistry · 461d
Cleared Aug 04, 2014
SKAFFOLD NMX BONE VOID FILLER
K132211 · MQV
Skeletal Kinetics, LLC
Orthopedic · 384d
Cleared Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
K140880 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 119d
Cleared Aug 04, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
K141496 · MUD
Reflectance Medical, Inc.
Cardiovascular · 59d
Cleared Aug 04, 2014
UNIMICRO SUCTION IRRIATION TUBING SET
K141592 · GCJ
Unimicro Medical Systems (Shenzhen)...
General & Plastic Surgery · 52d
Cleared Aug 04, 2014
AS20 COMPOSITE GRAFT
K141746 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Aug 04, 2014
LOGIQ V5/LOGIQ V3
K141768 · IYN
Ge Healthcare
Radiology · 34d
Cleared Aug 04, 2014
MEDICAL LCD MONITOR
K141891 · PGY
Kostec Co., Ltd.
Radiology · 21d
Cleared Aug 01, 2014
PASSPORT SERIES PATIENT MONITORS
K132662 · MHX
Shenzhen Mindray Biomedical...
Cardiovascular · 340d
Cleared Aug 01, 2014
TEBCO-W
K132892 · DXG
Bomed, Inc.
Cardiovascular · 319d
Cleared Aug 01, 2014
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K133461 · JEY
Stryker
Dental · 262d
Cleared Aug 01, 2014
ZOLL X SERIES
K133484 · MKJ
Zoll Medical Corp
Cardiovascular · 261d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · JWY
Thermo Fisher Scientific
Microbiology · 226d
Cleared Aug 01, 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · KCT
Intuitive Surgical
General Hospital · 221d
Cleared Aug 01, 2014
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO...
K140100 · NBW
Nipro Diagnostics, Inc.
Chemistry · 198d
Cleared Aug 01, 2014
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K140551 · MQB
Perkinelmer, Inc.
Radiology · 150d
Cleared Aug 01, 2014
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
K140953 · KOD
Convatec, Ltd.
Gastroenterology & Urology · 109d
Cleared Aug 01, 2014
ENSIZOR ENDOSCOPIC SCISSORS
K141058 · OCZ
Slater Endoscopy, LLC
Gastroenterology & Urology · 99d
Cleared Aug 01, 2014
NATURAL RUBBER LATEX MALE CONDOMS
K141059 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 99d
Cleared Aug 01, 2014
REMOTEYE VIEWER
K141061 · LLZ
Neologica S.R.L.
Radiology · 99d
Cleared Aug 01, 2014
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
K141302 · LLZ
Vital Images, Inc.
Radiology · 74d
Cleared Aug 01, 2014
HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
K141353 · BTT
Teleflexmedical, Inc.
Anesthesiology · 70d
Cleared Aug 01, 2014
SMC ACUPUNCTURE NEEDLE
K141473 · MQX
Smc Intl., Inc.
General Hospital · 59d