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
80569–80592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2000
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · LJT
Arrow Intl., Inc.
General Hospital · 31d
Cleared Oct 27, 2000
MITEK CUFFTACK
K003076 · MAI
Mitek Products
Orthopedic · 24d
Cleared Oct 26, 2000
PHOENIX DIGITAL EEG
K002316 · GWQ
Axon Systems, Inc.
Neurology · 87d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · JTN
Hardy Diagnostics
Microbiology · 84d
Cleared Oct 26, 2000
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Oct 26, 2000
EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
K002531 · LNH
Toshiba America Mri, Inc.
Radiology · 71d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · DGC
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561 · CZJ
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002563 · DEH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002564 · DFH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT...
K002577 · DWJ
Medivance, Inc.
Cardiovascular · 69d
Cleared Oct 26, 2000
ABX MICROS CRP
K002646 · GKZ
Abx Diagnostics
Hematology · 63d
Cleared Oct 26, 2000
HARDYDISK LOMEFLOXACIN, 10MCG
K002660 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK CEFOTETAN, 30MCG
K002661 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Hardy Diagnostics
Microbiology · 62d
Cleared Oct 26, 2000
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · KKX
Gyrus Ent LLC
General Hospital · 57d
Cleared Oct 26, 2000
300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC
K002880 · IYN
Pie Medical
Radiology · 41d
Cleared Oct 26, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/FS
K003194 · FYA
Stackhouse, Inc.
General Hospital · 14d
Cleared Oct 26, 2000
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K003232 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 9d
Cleared Oct 26, 2000
LITEAIRE
K993101 · CAF
Thayer Medical Corp.
Anesthesiology · 406d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 25, 2000
BURR HOLE COVER, MODEL XX
K001096 · GXR
Image-Guided Neurologics, Inc.
Neurology · 204d
Cleared Oct 25, 2000
PIPER
K001295 · MUJ
Rtek Medical Systems, LLC
Radiology · 184d