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
75961–75984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · KHE
Alfa Scientific Designs, Inc.
Hematology · 45d
Cleared Jun 17, 2002
CARDIOSPECT D90/CARDIO CAM
K021823 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 13d
Cleared Jun 14, 2002
AIRCAST, MODEL #3011
K013297 · JOW
Millenium Reprocessing Services, Inc.
Cardiovascular · 254d
Cleared Jun 14, 2002
ECHO-SCREEN T, TA, TD, TDA, TC
K013977 · GWJ
Fischer-Zoth Audiologic Systems, Inc.
Neurology · 193d
Cleared Jun 14, 2002
ENDOMAP
K014113 · HAW
Siemens Medical Solutions USA, Inc.
Neurology · 182d
Cleared Jun 14, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL...
K020857 · DRN
Vasomedical, Inc.
Cardiovascular · 88d
Cleared Jun 14, 2002
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL,...
K020896 · DTE
Osypka Medical, Inc.
Cardiovascular · 87d
Cleared Jun 14, 2002
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
K020907 · IKT
Medicotest A/S
Neurology · 86d
Cleared Jun 14, 2002
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · GCJ
Sopro
General & Plastic Surgery · 85d
Cleared Jun 14, 2002
RADIUS SNARE
K021441 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 39d
Cleared Jun 14, 2002
HEMOGLOBIN A1C CONTROL
K021484 · LCP
Canterbury Scientific , Ltd.
Hematology · 37d
Cleared Jun 14, 2002
SECURE RELINE/PICKUP MATERIAL
K021586 · EBI
Imtec Corp.
Dental · 31d
Cleared Jun 14, 2002
MEDGEM
K021605 · BZL
Healthetech, Inc.
Anesthesiology · 29d
Cleared Jun 14, 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · IOR
Vestil Manufacturing Corp.
Physical Medicine · 8d
Cleared Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K013022 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 279d
Cleared Jun 13, 2002
X-IMAGE DIGITAL X-RAY SYSTEM
K020588 · MUH
Escape Technology, Inc.
Radiology · 111d
Cleared Jun 13, 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603 · DCN
Good Biotech Corp.
Chemistry · 108d
Cleared Jun 13, 2002
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
K020630 · IYN
Ultrasonix Medical Corporation
Radiology · 107d
Cleared Jun 13, 2002
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K020706 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
K020707 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV V VCA IGM ELISA KIT MODEL# EBM-200
K020717 · GNP
Pan Bio Pty. , Ltd.
Microbiology · 100d
Cleared Jun 13, 2002
DEROYAL SURGICAL, UMBILICUP
K020753 · KSR
Deroyal
Hematology · 98d
Cleared Jun 13, 2002
NUVASIVE MESH
K020853 · EZX
Nuvasive, Inc.
General & Plastic Surgery · 90d
Cleared Jun 13, 2002
SPATOUCH PHOTOEPILATION SYSTEM
K020856 · GEX
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 90d