FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123049–123072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
K905857 · GJS
Helena Laboratories
Hematology · 75d
Cleared Feb 27, 1991
DISPOSABLE INTRODUCER SHEATH
K910079 · KDC
Applied Vascular Devices, Inc.
General & Plastic Surgery · 50d
Cleared Feb 27, 1991
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED
K910133 · CHJ
Olympus Corp.
Chemistry · 49d
Cleared Feb 27, 1991
ELECTROPHORESIS CONTROL
K910160 · JIT
Seradyn, Inc.
Chemistry · 43d
Cleared Feb 27, 1991
COBAS ALPHA
K910222 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Feb 27, 1991
PHOSPHORUS (INORGANIC) TEST SYSTEM
K910296 · CEO
Biochemical Trade, Inc.
Toxicology · 35d
Cleared Feb 27, 1991
FLOXIN SUSCEPTIBILITY TEST DISKS
K910412 · JTN
Difco Laboratories, Inc.
Microbiology · 29d
Cleared Feb 26, 1991
SLIDEX ROTA-KIT 2
K895805 · LIQ
Vitek Systems, Inc.
Microbiology · 516d
Cleared Feb 26, 1991
SUNGLASSES
K902343 · HQY
Jasco Products Co., Inc.
Ophthalmic · 277d
Cleared Feb 26, 1991
ES-1000SP II SMART DOP
K903026 · DPW
Koven and Assoc., Inc.
Cardiovascular · 231d
Cleared Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
K903468 · GGP
Baxter Healthcare Corp
Hematology · 209d
Cleared Feb 26, 1991
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 202d
Cleared Feb 26, 1991
VITREORETINAL INFUSION CANNULA
K904074 · HMX
Visitec Co.
Ophthalmic · 175d
Cleared Feb 26, 1991
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
K904501 · LJZ
Medical Diagnostic Technologies, Inc.
Microbiology · 147d
Cleared Feb 26, 1991
HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)
K904645 · HET
Hall Medical Laboratories
Obstetrics & Gynecology · 138d
Cleared Feb 26, 1991
COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
K904812 · EBF
Alpha-Dent
Dental · 124d
Cleared Feb 26, 1991
ECLIPSE ICA CHOLESTEROL
K905145 · CHH
Biotope, Inc.
Chemistry · 103d
Cleared Feb 26, 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · LWJ
Depuy, Inc.
Orthopedic · 95d
Cleared Feb 26, 1991
DENTHESIVE
K905302 · KLE
Kulzer, Inc.
Dental · 90d
Cleared Feb 26, 1991
WLW
K905320 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · EIH
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
MAXIGOLD
K905327 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
WILL-CERAM W
K905329 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
GGT REAGENT
K905618 · JPZ
Amresco, Inc.
Chemistry · 74d