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
77233–77256 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2002
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
K014120 · CDZ
Diagnostics Biochem Canada, Inc.
Chemistry · 53d
Cleared Feb 08, 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · MQG
Cook Urological, Inc.
Obstetrics & Gynecology · 51d
Cleared Feb 08, 2002
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
K020075 · DQA
Dolphin Medical, Inc.
Anesthesiology · 30d
Cleared Feb 08, 2002
MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K020088 · GXN
Bioplate, Inc.
Neurology · 29d
Cleared Feb 08, 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · DZE
Institut Straumann AG
Dental · 28d
Cleared Feb 08, 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · HRY
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Feb 08, 2002
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
K020284 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 11d
Cleared Feb 07, 2002
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K002604 · DSI
Invivo Research, Inc.
Cardiovascular · 534d
Cleared Feb 07, 2002
FAST SET PUTTY
K012589 · GXP
Synthes (Usa)
Neurology · 181d
Cleared Feb 07, 2002
GELZONE
K013732 · MDA
Implantech Associates, Inc.
General & Plastic Surgery · 90d
Cleared Feb 07, 2002
PEACE OF MIND HOME DRUG TEST
K013778 · MVO
Advantage Diagnostics Corp.
Toxicology · 86d
Cleared Feb 07, 2002
D.SIGN 59
K013809 · EJS
Ivoclar Vivadent, Inc.
Dental · 84d
Cleared Feb 07, 2002
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
K013889 · PKL
Inscope, LLC
Gastroenterology & Urology · 76d
Cleared Feb 07, 2002
HELIOMOLAR HB TRANSLUCENT SHADES
K013929 · EBF
Ivoclar Vivadent, Inc.
Dental · 71d
Cleared Feb 07, 2002
TASK FORCE MONITOR 3040
K014063 · DSB
Cnsystems Medizintechnik GmbH
Cardiovascular · 58d
Cleared Feb 07, 2002
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
K014144 · EBF
Afp Imaging Corp.
Dental · 51d
Cleared Feb 07, 2002
SMARTEPIL
K020107 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d
Cleared Feb 06, 2002
GENTLE COLONICS IRRIGATION SYSTEM
K002102 · KPL
Gentle Colonics, Inc.
Gastroenterology & Urology · 574d
Cleared Feb 06, 2002
MICROLIGHT 830 LASER SYSTEM
K010175 · NHN
Microlight Corporation of America
Physical Medicine · 384d
Cleared Feb 06, 2002
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
K011540 · MHX
Datascope Corp.
Cardiovascular · 264d
Cleared Feb 06, 2002
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
K012439 · LLZ
Radco Data AB
Radiology · 190d
Cleared Feb 06, 2002
CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW...
K012601 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH...
K012606 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
K012612 · JOW
Clearmedical, Inc.
Cardiovascular · 177d