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
75457–75480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
K021110 · JWY
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111 · LTT
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSTREP PLUS PANEL, AZITHROMYCIN
K021169 · JWY
Dade Microscan, Inc.
Microbiology · 56d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
K021188 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Jun 06, 2002
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE...
K021220 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 76d
Cleared Jun 06, 2002
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE
K021353 · LYZ
Glormed Intl., Inc.
General Hospital · 41d
Cleared Jun 06, 2002
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
K021445 · JWY
Ab Biodisk
Microbiology · 31d
Cleared Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A...
K021462 · DSP
Arrow Intl., Inc.
Cardiovascular · 30d
Cleared Jun 06, 2002
MODEL 1133 IVD PC VERSION
K021463 · IYE
Sun Nuclear Corp.
Radiology · 30d
Cleared Jun 06, 2002
GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
K021494 · HCG
Boston Scientific, Target
Neurology · 28d
Cleared Jun 06, 2002
OSCAR, MODEL OE3000
K021502 · LZV
Orthosonics, Ltd.
Orthopedic · 28d
Cleared Jun 06, 2002
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K021506 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 28d
Cleared Jun 06, 2002
PAINDOC
K021518 · GZB
Advanced Neuromodulation Systems
Neurology · 27d
Cleared Jun 06, 2002
ARTHROCARE CONTROLLER, AUTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
K021519 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Jun 06, 2002
VAXCEL PICC WITH PASV VALVE TECHNOLOGY
K021704 · LJS
Catheter Innovations, Inc.
General Hospital · 14d
Cleared Jun 05, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
K013654 · JJF
Precision Systems, Inc.
Toxicology · 211d
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902 · IYN
U-Systems, Inc.
Radiology · 191d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772 · KTT
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 05, 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
K020779 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 86d
Cleared Jun 05, 2002
ENDOSCOPIC LIGHT SOURCE XL202/L3
K020889 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 78d
Cleared Jun 05, 2002
VACURECT VACUUM CONSTRICTION DEVICE
K020969 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260 · KRO
Biomet, Inc.
Orthopedic · 47d
Cleared Jun 05, 2002
ASCENT ALL-POLY PS TIBIAL BEARINGS
K021559 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Jun 05, 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · DZE
Nobel Biocare Uas, Inc.
Dental · 22d