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
122449–122472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1991
3M MODEL 8243 ITE HEARING AID
K910761 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8244 ITE HEARING AID
K910762 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8245 ITE HEARING AID
K910763 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 27, 1991
SOLUSPONGE - S-99
K901564 · QSY
Sie Medical Supply Co., Inc.
General & Plastic Surgery · 330d
Cleared Feb 27, 1991
GUILD MAXOX GENERATOR (MAXOX)
K901712 · CAW
Guild Assoc., Inc.
Anesthesiology · 320d
Cleared Feb 27, 1991
DIA HEALING CAP
K902434 · DZE
Dental Imaging Assoc., Inc.
Dental · 272d
Cleared Feb 27, 1991
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
K904364 · IYE
Varian Assoc., Inc.
Radiology · 156d
Cleared Feb 27, 1991
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · KWY
Exactech, Inc.
Orthopedic · 90d
Cleared Feb 27, 1991
LAP DISCS
K905472 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 83d
Cleared Feb 27, 1991
MODIFIED SITE PERISTALTIC FOOTSWITCH
K905620 · EBW
Site Microsurgical Systems, Inc.
Dental · 75d
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