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
39241–39264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133106 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133120 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
ILUMINAGE SKIN SMOOTHING LASER
K133473 · OHS
Cynosure, Inc.
General & Plastic Surgery · 64d
Cleared Jan 14, 2014
TASMIN R
K123758 · MQP
Signus Medizintechnik GmbH
Orthopedic · 403d
Cleared Jan 14, 2014
COSENSE CO MONITOR
K130036 · CCJ
Capnia, Inc.
Anesthesiology · 372d
Cleared Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
K130692 · LNH
Aspect Imaging, Ltd.
Radiology · 307d
Cleared Jan 14, 2014
SYNTHETIC ABSORBABLE SUTURE
K130735 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 302d
Cleared Jan 14, 2014
SYNTHETIC ABSORBABLE SUTURE
K130737 · GAM
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 302d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Jan 14, 2014
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · ELM
Ivoclar Vivadent, Inc.
Dental · 112d
Cleared Jan 14, 2014
TIGER SPINE SYSTEM
K133369 · NKB
Corelink, LLC
Orthopedic · 74d
Cleared Jan 14, 2014
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE,...
K133499 · GDW
Suzhou Beinuo Medical Equipment Co. ,...
General & Plastic Surgery · 61d
Cleared Jan 13, 2014
CT PULMONARY ANALYSIS
K130552 · JAK
Qi Imaging, LLC
Radiology · 315d
Cleared Jan 13, 2014
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130674 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 306d
Cleared Jan 13, 2014
K SERIES CPAP SYSTEMS
K130828 · BZD
Curative Medical, Inc.
Anesthesiology · 293d
Cleared Jan 13, 2014
CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA...
K131410 · CCK
Southmedic, Inc.
Anesthesiology · 243d
Cleared CT Jan 13, 2014
S9 CRONULLA FOR HER
K132606 · BZD
Resmed, Ltd.
Anesthesiology · 146d
Cleared Jan 13, 2014
MODIFIED TREVO PROVUE RETRIEVER
K132641 · NRY
Concentric Medical, Inc.
Neurology · 140d
Cleared Jan 13, 2014
PROXIFAST ABSORBABLE STAPLE
K132669 · GDW
Surgimatix, Inc.
General & Plastic Surgery · 139d
Cleared Jan 13, 2014
MIXING SYRINGE SYSTEM
K133021 · FMF
Zimmer Knee Creations, Inc.
General Hospital · 109d
Cleared Jan 13, 2014
SANTIS PEDICLE SCREW SYSTEM
K133063 · NKB
Lanterna Medical Technologies
Orthopedic · 108d
Cleared Jan 13, 2014
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
K133066 · NKB
Spineselect, LLC
Orthopedic · 108d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407 · CHL
Instrumentation Laboratory CO
Chemistry · 68d
Cleared Jan 13, 2014
ULTRABLOX
K133684 · PDK
Bloxr Corporation
Radiology · 42d