Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
175945–175968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1976
BONDING AGENT, PRESTIGE
K760324 · KLE
Lee Pharmaceuticals
Dental · 8d
Cleared Aug 03, 1976
SURGICAL INSTRUMENTS, ORTHOPEDIC
K760325 · HTX
Depuy, Inc.
Orthopedic · 8d
Cleared Jul 26, 1976
ARCH SUPPORT (ARCH AID)
K760001
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
KNEE AID
K760002 · IQI
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
CAST MATERIAL (WICKET STOCKINETTE)
K760003 · ITG
Zimmer, Inc.
Physical Medicine · 61d
Cleared Jul 26, 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010 · CIT
The Dow Chemical Co.
Chemistry · 46d
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