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
83521–83544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2000
NIPRO INSULIN SYRINGE
K000144 · FMF
Nipro Medical Corp.
General Hospital · 24d
Cleared Feb 11, 2000
AUDIOSCREENER OAE
K000184 · EWO
Kedly, Inc.
Ear, Nose, Throat · 22d
Cleared Feb 11, 2000
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
K000225 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 18d
Cleared Feb 11, 2000
CAP PORP, CAP TORP
K000256 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · MWI
Eastman Kodak Company
Cardiovascular · 463d
Cleared Feb 11, 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K991397 · GZJ
Sein Electronics Co., Ltd.
Neurology · 296d
Cleared Feb 11, 2000
T-GEAR, MODEL TG/400-700
K993224 · DZB
Dontech Products B.V.
Dental · 137d
Cleared Feb 11, 2000
CAVERMAP SURGICAL AID
K993436 · FGM
Uromed Corp.
Gastroenterology & Urology · 122d
Cleared Feb 11, 2000
GASTRO-INTESTINAL SYSTEM EN-410WM
K993704 · FDA
Fujinon, Inc.
Gastroenterology & Urology · 101d
Cleared Feb 11, 2000
EXETER CERAMIC FEMORAL HEADS
K993889 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Feb 11, 2000
HARDYDISK CHLORAMPHENICOL, 30MCG
K994089 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK GENTAMICIN, 10MCG
K994091 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 11, 2000
HARDYDISK CEFIXIME, 5MCG
K994129 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Feb 10, 2000
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET...
K000017 · FPA
Rd Medical Mfg., Inc.
General Hospital · 38d
Cleared Feb 10, 2000
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
K000052 · ITY
Dynarad Corp.
Radiology · 34d
Cleared Feb 10, 2000
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
K000090 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 28d
Cleared Feb 10, 2000
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
K000101 · LIT
Guidant Corp.
Cardiovascular · 28d
Cleared Feb 10, 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · MRN
Datex-Ohmeda
Anesthesiology · 27d
Cleared Feb 10, 2000
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
K000274 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 10d
Cleared Feb 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
K000331 · JIS
Beckman Coulter, Inc.
Chemistry · 50d
Cleared Feb 10, 2000
EXEL I.V. BLOOD LINE SET
K992039 · FJK
Exelint Intl. Co.
Gastroenterology & Urology · 238d
Cleared Feb 10, 2000
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
K992176 · EBI
St. George Technology, Inc.
Dental · 227d
Cleared Feb 10, 2000
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
K992467 · LMA
Dba Systems, Inc.
Radiology · 202d
Cleared Feb 10, 2000
I-STAT SYSTEM
K992571 · JBP
I-Stat Corp.
Hematology · 192d