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
77401–77424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2001
BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE...
K012335 · JOJ
Albert Browne , Ltd.
General Hospital · 69d
Cleared Oct 01, 2001
BAYER ADVIA SYSTEM
K012340 · JMO
Bayer Corp.
Chemistry · 69d
Cleared Oct 01, 2001
NAVIGUS II TRAJECTORY GUIDE
K012366 · HAW
Image-Guided Neurologics, Inc.
Neurology · 67d
Cleared Oct 01, 2001
BIS/EEG MODULE
K012466 · OLW
General Electric Medical Systems...
Neurology · 61d
Cleared Oct 01, 2001
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT...
K012709 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 48d
Cleared Oct 01, 2001
CTS-485 ULTRASOUND IMAGING SYSTEM
K012772 · IYO
Shantou Institute of Ultrasonic...
Radiology · 45d
Cleared Oct 01, 2001
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
K012786 · LZA
Shamrock Manufacturing Company
General Hospital · 42d
Cleared Oct 01, 2001
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT...
K012876 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 35d
Cleared Oct 01, 2001
SONICWAVE SONIC PLAQUE REMOVER
K012914 · JEQ
Homedics, Inc.
Dental · 32d
Cleared Oct 01, 2001
BELLEGLASS HP ENAMEL 2
K013007 · EBF
Sybron Dental Specialties, Inc.
Dental · 25d
Cleared Oct 01, 2001
EXHALE PROBE
K013111 · EOQ
Broncus Technologies, Inc.
Radiology · 13d
Cleared Sep 28, 2001
OMNICARE DENTAL IMPLANT SYSTEM
K000035 · DZE
Omnicare Dental Implant Center
Dental · 631d
Cleared Sep 28, 2001
MIS IMPLANT SYSTEM DECIVE
K003191 · DZE
Mis Implants Technologies , Ltd.
Dental · 353d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Sep 28, 2001
UNIVERSAL DENTAL COPING (UDC)
K010467 · DZE
Paxmed International
Dental · 224d
Cleared Sep 28, 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
K010592 · FIP
Aqua Water Treatment, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 28, 2001
UCLA AND UNIVERSAL ABUTMENTS
K010619 · DZE
Diamodent
Dental · 211d
Cleared Sep 28, 2001
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 199d
Cleared Sep 28, 2001
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K010882 · DZE
Blue Sky Bio
Dental · 189d
Cleared Sep 28, 2001
VYGON SPLIT CANNULA INTRODUCER
K010913 · DYB
Vygon Corp.
Cardiovascular · 185d
Cleared Sep 28, 2001
2010 PLUS HOLTER FOR WINDOWS
K010949 · MLO
Agilent Technologies
Cardiovascular · 183d
Cleared Sep 28, 2001
RANDOX LIPOPROTEIN
K011568 · JIS
Randox Laboratories, Ltd.
Chemistry · 130d
Cleared Sep 28, 2001
UNIPLANT DENTAL IMPLANT SYSTEM
K011574 · DZE
Universal Implant Systems, Inc.
Dental · 129d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · HRS
Synthes (Usa)
Orthopedic · 84d