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
87577–87600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1998
ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
K981363 · LCM
Tcpi, Inc.
Toxicology · 251d
Cleared Dec 22, 1998
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K981554 · HNO
Micra Instruments , Ltd.
Ophthalmic · 235d
Cleared Dec 22, 1998
OPTICOAT T3 EIA KIT
K981824 · CDP
Biotecx Laboratories, Inc.
Chemistry · 214d
Cleared Dec 22, 1998
CS/3 COMPACT AIRWAY MODULE, M-COVX
K982091 · MHX
Datex-Engstrom, Inc.
Cardiovascular · 190d
Cleared Dec 22, 1998
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES,...
K982344 · LPL
Wesley Jessen Corp.
Ophthalmic · 169d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV
Corgenix, Inc.
Immunology · 161d
Cleared Dec 22, 1998
TYPE 3 FEMORAL COMPONENTS
K983404 · LZO
Howmedica Corp.
Orthopedic · 85d
Cleared Dec 22, 1998
SUPER PORCELAIN STAIN- PURE WHITE
K983470 · EIH
Noritake Co., Inc.
Dental · 82d
Cleared Dec 22, 1998
SUPER SEAL
K983477 · EJK
Phoenix Dental, Inc.
Dental · 81d
Cleared Dec 22, 1998
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
K983653 · DRF
Cardiac Pathways Corp.
Cardiovascular · 64d
Cleared Dec 22, 1998
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
K983773 · LPL
Benz Research and Development Corp.
Ophthalmic · 57d
Cleared Dec 22, 1998
DEPUY ACE TIMAX META PLATE
K983853 · HRS
Depuy Ace Medical Co.
Orthopedic · 53d
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · KWQ
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · KWP
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 22, 1998
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914 · GGP
Corgenix, Inc.
Hematology · 48d
Cleared Dec 22, 1998
CO2 LASER COUPLER
K983965 · GEX
L.A.S.E.R., Inc.
General & Plastic Surgery · 46d
Cleared Dec 22, 1998
ADVENT
K984112 · EBF
Bisco, Inc.
Dental · 35d
Cleared Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173 · MID
Zeus Scientific, Inc.
Immunology · 32d
Cleared Dec 22, 1998
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
K984319 · JJX
Bio-Rad
Chemistry · 19d
Cleared Dec 22, 1998
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
K984327 · JJX
Bio-Rad
Chemistry · 19d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462 · LLL
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · LKJ
Bio-Rad
Immunology · 6d