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
81073–81096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2000
WUJIN #3 TIBIAL NAIL
K002325 · JDS
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Oct 30, 2000
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
K002356 · KRR
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 30, 2000
ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER
K002676 · DYB
Guidant Cardiac and Vascular Surgery
Cardiovascular · 63d
Cleared Oct 30, 2000
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
K003061 · KWQ
Synthes
Orthopedic · 28d
Cleared Oct 30, 2000
CORDIS SLALOM PTA BALLOON CATHETER
K003159 · LIT
Cordis Corp.
Cardiovascular · 20d
Cleared Oct 27, 2000
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
K000317 · GEX
Tissue Medical Lasers, Inc.
General & Plastic Surgery · 269d
Cleared Oct 27, 2000
SUPER NOVA, ACUBEAM
K001179 · ILY
Light Force Therapy, Inc.
Physical Medicine · 199d
Cleared Oct 27, 2000
ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
K001972 · MSX
Visicu, Inc.
Cardiovascular · 121d
Cleared Oct 27, 2000
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 80d
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