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
39313–39336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 2014
D-RAD SMART PACK
K132296 · HRS
Smith & Nephew, Inc.
Orthopedic · 168d
Cleared CT Jan 07, 2014
MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE...
K132581 · GDW
Cardica, Inc.
General & Plastic Surgery · 144d
Cleared Jan 07, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
K132677 · IYN
B-K Medical Aps
Radiology · 132d
Cleared Jan 07, 2014
AXIA RADIAL HEAD SYSTEM
K132735 · KWI
Imds (Innovative MEdical Device...
Orthopedic · 126d
Cleared Jan 07, 2014
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD
K133167 · GEI
Intuitive Surgical, Inc.
General & Plastic Surgery · 82d
Cleared Jan 07, 2014
IDSS SLC
K133413 · FTA
Black Diamond Video
General & Plastic Surgery · 61d
Cleared Jan 07, 2014
ENDOSCOPIC SUTURE CUTTER
K133736 · OCZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 06, 2014
OPTIFLUX ULTRA DIALYZER
K123262 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 445d
Cleared Jan 06, 2014
LATERAL SYNFIX
K131276 · OVD
Synthes USA Products, LLC
Orthopedic · 245d
Cleared Jan 06, 2014
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
K131461 · OLP
Led Intellectual Properties, LLC
General & Plastic Surgery · 231d
Cleared Jan 06, 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · NBW
ACON Laboratories, Inc.
Chemistry · 230d
Cleared Jan 06, 2014
SAKURA STEAM STERILIZER ASSR
K132439 · FLE
Sakura Seiki Co., Ltd.
General Hospital · 154d
Cleared Jan 06, 2014
ULTRASOUND SCANNER PRO FOCUS 2202
K132685 · IYN
B-K Medical Aps
Radiology · 131d
Cleared Jan 06, 2014
ACUMED HAND PLATING SYSTEM
K132769 · HRS
Acumed, LLC
Orthopedic · 124d
Cleared Jan 06, 2014
DISTALOCK TIBIAL IM NAIL SYSTEM
K132830 · HSB
Dgimed Ortho, Inc.
Orthopedic · 118d
Cleared Jan 06, 2014
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2...
K133686 · LLZ
Jvckenwood Corporation
Radiology · 35d
Cleared Jan 06, 2014
INTONEMV
K133826 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 20d
Cleared Jan 03, 2014
FMWAND FERROMAGNETIC SURGICAL SYSTEM
K130606 · HGI
Domain Surgical, Inc.
Obstetrics & Gynecology · 302d
Cleared Jan 03, 2014
WAVE 2G, SOUL
K130937 · KLW
Hansaton Akustik GmbH
Ear, Nose, Throat · 274d
Cleared Jan 03, 2014
SYNGO.VIA WEB VIEWER
K130998 · LLZ
Siemens AG Medical Solutions
Radiology · 268d
Cleared Jan 03, 2014
SIREN EPCR SUITE
K131272 · DXJ
Medusa Medical Technologies, Inc.
Cardiovascular · 245d
Cleared Jan 03, 2014
PRISMAFLEX SYSTEM 7.10
K131516 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 220d
Cleared Jan 03, 2014
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
K131880 · OVE
Spinefrontier, Inc.
Orthopedic · 192d
Cleared Jan 03, 2014
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL...
K132399 · JFY
Elitechgroup
Chemistry · 155d