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
46273–46296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2011
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY
K112263 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446 · MUJ
Tomotherapy Incorporated
Radiology · 44d
Cleared Oct 07, 2011
MULTIPLE
K112460 · IYE
Larson Medical Products, Inc.
Radiology · 42d
Cleared Oct 07, 2011
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 28d
Cleared Oct 07, 2011
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · MQP
Globus Medical, Inc.
Orthopedic · 16d
Cleared Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Oct 06, 2011
ERASE HAND- HELD CONTROLLER
K101592 · GXD
Cheng Medical, Corporation
Neurology · 486d
Cleared Oct 06, 2011
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K103485 · MUE
General Electric Company
Radiology · 314d
Cleared Oct 06, 2011
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE
K103625 · CBK
Draeger Medical Systems, Inc.
Anesthesiology · 300d
Cleared Oct 06, 2011
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS)
K103643 · DRG
Ascot Technologies, Inc.
Cardiovascular · 297d
Cleared Oct 06, 2011
ENDOFLIP ECD
K110531 · FED
Crospon, Ltd.
Gastroenterology & Urology · 224d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579 · CDD
Abbott Laboratories
Chemistry · 219d
Cleared Oct 06, 2011
EASYLOCK OSTEOSYSTEM
K111266 · HRS
TriMed, Inc.
Orthopedic · 155d
Cleared Oct 06, 2011
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS...
K111343 · FXX
Crosstex International, Inc.
General Hospital · 146d
Cleared Oct 06, 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · CGA
ACON Laboratories, Inc.
Chemistry · 143d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Carestream Health, Inc.
Radiology · 122d
Cleared Oct 06, 2011
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647 · GWF
Inomed Medizintechnik GmbH
Neurology · 115d
Cleared Oct 06, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · MNI
K2m, Inc.
Orthopedic · 80d
Cleared Oct 06, 2011
XL EXTRACTION CATHETER
K112571 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Oct 06, 2011
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER
K112579 · DQY
Avinger, Inc.
Cardiovascular · 30d
Cleared Oct 05, 2011
SINGHMED ROOLIP MANIPULATOR
K110819 · HEW
J.Singh Instruments
Obstetrics & Gynecology · 196d
Cleared Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · HWC
Zimmer, Inc.
Orthopedic · 134d
Cleared Oct 05, 2011
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · FIP
Ameriwater
Gastroenterology & Urology · 106d
Cleared Oct 05, 2011
EXETER X3 RIMFIT ACETABULAR CUP
K111848 · JDI
Stryker Corp.
Orthopedic · 98d