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
47977–48000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2011
PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
K103375 · GEI
Medtek Devices, Inc.
General & Plastic Surgery · 120d
Cleared Mar 16, 2011
ESCALADE ACETABULAR CUP SYSTEM
K103384 · LPH
Ortho Development
Orthopedic · 118d
Cleared Mar 16, 2011
GETINGE 400HC/500HC SERIES STEAM STERILIZER
K103504 · FLE
Getinge Sourcing, LLC
General Hospital · 110d
Cleared Mar 16, 2011
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K103720 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 85d
Cleared Mar 16, 2011
ZENOFLEX DIMENSION
K103773 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 79d
Cleared Mar 16, 2011
MODALIXX
K110108 · LLZ
Ampronix, Inc.
Radiology · 61d
Cleared Mar 16, 2011
DOPPLER MONITOR
K110347 · DPW
Cook Vascular, Inc.
Radiology · 37d
Cleared Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
K110412 · JJX
Immunodiagnostic Systems , Ltd.
Chemistry · 30d
Cleared Mar 16, 2011
MIRAGE MICRO
K110444 · BZD
Resmed, Ltd.
Anesthesiology · 28d
Cleared Mar 16, 2011
RELIANCE ENDOSCOPE PROCESSING SYSTEM
K110453 · NZA
STERIS Corporation
General Hospital · 28d
Cleared Mar 16, 2011
BACKSTOP CATHETER
K110491 · KOD
Pluromed, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 15, 2011
MEMOMETAL NAVIS BONE PLATING SYSTEM
K101930 · HRS
Memometal Technologies
Orthopedic · 249d
Cleared Mar 15, 2011
SINGLE CANNULA EXTENDED APPLICATOR
K102563 · KYZ
Micromedics, Inc.
General Hospital · 189d
Cleared Mar 15, 2011
SPIDER STANDARD AND ADVANCED
K102839 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 167d
Cleared Mar 15, 2011
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
K103404 · KWT
Zimmer GmbH
Orthopedic · 116d
Cleared Mar 15, 2011
ALLERGEAZE R CLEAR
K103409 · KXF
Smartpractice
General Hospital · 113d
Cleared Mar 15, 2011
ALTUM ANTERIOR CERVICAL PLATE
K103505 · KWQ
Spinecraft, LLC
Orthopedic · 106d
Cleared Mar 15, 2011
STAR 50 N
K103686 · MWI
Larsen & Toubro Limited
Cardiovascular · 88d
Cleared Mar 15, 2011
ESSENTIAL MRI PATIENT MONITOR
K103700 · DQA
Invivo Corporation
Anesthesiology · 85d
Cleared Mar 15, 2011
DEPUY ATTUNE TOTAL KNEE SYSTEM
K103756 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 82d
Cleared Mar 15, 2011
BELIMED STEAM STERILIZER MST-V
K103841 · FLE
Sauter AG
General Hospital · 83d
Cleared Mar 15, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110018 · DXN
Andon Health Co, Ltd.
Cardiovascular · 71d
Cleared Mar 14, 2011
STCC
K100698 · ODP
Cardinal Spine, LLC
Orthopedic · 368d
Cleared Mar 14, 2011
NEWFIX EXTERNAL FIXATION SYSTEM
K101338 · KTT
Technologia Y Diseno Industrial, S.A...
Orthopedic · 306d