FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76129–76152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 06, 2002
MARK 5000 QUADRATURE SHOULDER COIL
K013854 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Feb 06, 2002
POWDERFREE LATEX SURGEON'S GLOVES
K013914 · KGO
Kanam Latex Industries Pvt. , Ltd.
General Hospital · 71d
Cleared Feb 06, 2002
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K014169 · FIP
Bob J. Johnson & Assoc., Inc.
Gastroenterology & Urology · 49d
Cleared Feb 06, 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · CAC
Boehringer Laboratories
Anesthesiology · 47d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · GGC
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Feb 06, 2002
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN...
K020168 · LON
Dade Behring, Inc.
Microbiology · 20d
Cleared Feb 06, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE...
K020173 · LON
Dade Behring, Inc.
Microbiology · 20d