FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76633–76656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 06, 2002
CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS
K012616 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
K012621 · JOW
Clearmedical, Inc.
Cardiovascular · 177d
Cleared Feb 06, 2002
OVUS CAPLESS SAFETY NEEDLE
K013006 · MEG
Ovus Systems
General Hospital · 153d
Cleared Feb 06, 2002
BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
K013717 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 90d
Cleared Feb 06, 2002
MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K013723 · ITX
Hitachi Medical Corp.
Radiology · 89d
Cleared Feb 06, 2002
ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
K013730 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 89d
Cleared Feb 06, 2002
HANDHELD GAMMA FINDER (HGF)
K013751 · IZD
Silicon Instruments Gmhb
Radiology · 85d
Cleared Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · HTY
Mitek Products
Orthopedic · 84d