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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54625–54648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2009
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
K082746 · DSP
Insightra Medical, Inc.
Cardiovascular · 115d
Cleared Jan 12, 2009
VITAL SIGNS MONITOR, MODEL: MD500B
K082787 · MWI
Beijing Choice Electronic Technololgy...
Cardiovascular · 111d
Cleared Jan 12, 2009
MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
K082905 · DXT
Medrad, Inc.
Cardiovascular · 104d
Cleared Jan 12, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082936 · LYZ
Zibo Litong Plastic Products Co., Ltd.
General Hospital · 103d
Cleared Jan 12, 2009
VOCO PROFLUORID L
K083036 · LBH
Voco GmbH
Dental · 90d
Cleared Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
K083145 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 81d
Cleared Jan 12, 2009
STINGRAY ELECTROSURGICAL FORCEPS
K083162 · GEI
Stingray Surgical Products, Inc.
General & Plastic Surgery · 77d
Cleared Jan 12, 2009
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K083240 · MBI
Arthrocare Corp.
Orthopedic · 70d
Cleared Jan 09, 2009
AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
K081767 · NQM
Amnisure International, LLC
Chemistry · 203d
Cleared Jan 09, 2009
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
K081956 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 184d
Cleared Jan 09, 2009
XYCOR SPINAL IMPLANT
K082466 · MQP
Vertebration,Inc
Orthopedic · 135d
Cleared Jan 09, 2009
V60 VENTILATOR, MODEL V8000
K082660 · MNT
Respironics California, Inc.
Anesthesiology · 119d
Cleared Jan 09, 2009
BIRTHTRACK (A.K.A. CLM)
K082704 · NPB
Barnev, Ltd.
Obstetrics & Gynecology · 115d
Cleared Jan 09, 2009
IMAGESVR PACS
K082808 · LLZ
Jaguar Technology Limited
Radiology · 107d
Cleared Jan 09, 2009
DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL...
K082863 · KNT
Dynarex Corporation
Gastroenterology & Urology · 102d
Cleared Jan 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · LYC
Medtronic Sofamor Danek
Dental · 101d
Cleared Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
K083060 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 87d
Cleared Jan 09, 2009
ELLEX INNOVATIVE IMAGING EYE CUBED V4
K083061 · IYO
Ellex, Inc.
Radiology · 87d
Cleared Jan 09, 2009
CONFIDANT, MODEL 2.6
K083331 · DRG
Confidant, Inc.
Cardiovascular · 58d
Cleared Jan 09, 2009
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
K083332 · LLZ
Nec Display Solutions , Ltd.
Radiology · 58d
Cleared Jan 09, 2009
LUBRICANO-ULTRASOUND
K083358 · MUI
Farco Pharma GmbH
Radiology · 87d
Cleared Jan 09, 2009
REVOLVE STABILIZATION SYSTEM
K083416 · NKB
Globus Medical, Inc.
Orthopedic · 52d
Cleared Jan 09, 2009
SONY UP-DF750 DIGITAL FILM IMAGER
K083522 · LMC
Sony Electronics, Inc.
Radiology · 44d
Cleared Jan 09, 2009
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
K083664 · CGA
Taidoc Technology Corporation
Chemistry · 30d