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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
175105–175128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1976
REAGENT, TRIGLYCERIDES
K760011 · CDT
The Dow Chemical Co.
Chemistry · 46d
Cleared Jul 26, 1976
KIT, RIA, HUMAN THYROID HORMONE
K760044 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 41d
Cleared Jul 26, 1976
MONITOR, GSR (NB-401)
K760084 · HCC
Narco Bio-Systems
Neurology · 35d
Cleared Jul 26, 1976
RADIOGRAPHIC UNIT, XRC-1
K760205 · KPR
Xrc, Inc.
Radiology · 17d
Cleared Jul 26, 1976
KIT, FOLATE RADIOASSAY SC.7
K760207 · CGN
Amersham Corp.
Chemistry · 17d
Cleared Jul 26, 1976
OXIMETER, CO-, IL MODEL 282
K760208 · KHG
Instrumentation Laboratory CO
Hematology · 17d
Cleared Jul 26, 1976
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209 · DHN
Zeus Scientific, Inc.
Immunology · 17d
Cleared Jul 26, 1976
RADIOIMMUNOASSAY
K760227 · CDX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Jul 26, 1976
SUTURE GUIDE
K760235
Cutter Laboratories, Inc.
Physical Medicine · 11d
Cleared Jul 26, 1976
BUR, SURGICAL CARBIDE
K760236 · HTT
Cutter Laboratories, Inc.
Orthopedic · 11d
Cleared Jul 26, 1976
IMPRESSION MATERIAL, TRIFLEX SILICONE
K760238 · ELW
Oratec Dental Products
Dental · 11d
Cleared Jul 26, 1976
CEMENT, ULTRA-BOND
K760239 · EMA
Oratec Dental Products
Dental · 11d
Cleared Jul 26, 1976
IMPRESSION MATERIAL, TRIFLEX SILICONE
K760240 · ELW
Oratec Dental Products
Dental · 11d
Cleared Jul 26, 1976
PROSTHESIS, RICHARDS MOD II KNEE
K760245 · HRY
Richard'S Medical Equip., Inc.
Orthopedic · 7d
Cleared Jul 26, 1976
BANDAGE, TRIANGULAR NO. 8068
K760250 · ILI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 7d
Cleared Jul 26, 1976
BITE STICK, DYNA
K760258 · JXL
Dyna-Med
Neurology · 6d
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · KRB
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065 · KRB
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
TRAY, ICED INJECTABLE (26420)
K760066 · DXL
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
K760067 · KRB
Instrumentation Laboratory CO
Cardiovascular · 35d
Cleared Jul 21, 1976
HEARING AID, S-522 FM
K760215 · ESD
Vicon Instrument Co.
Ear, Nose, Throat · 9d
Cleared Jul 21, 1976
PUTTY, ACCOE
K760225 · ELW
Coe Laboratories, Inc.
Dental · 9d
Cleared Jul 21, 1976
PASTE, ACCOE IMPRESSION
K760226 · ELW
Coe Laboratories, Inc.
Dental · 9d
Cleared Jul 21, 1976
IMPRESSION MATERIAL, DENTAL SILICON RTV
K760231 · ELW
Crown Delta Corp.
Dental · 7d