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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83017–83040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 10, 2000
MU PLUS
K992689 · IYE
Rad Therapy Solutions, Inc.
Radiology · 184d
Cleared Feb 10, 2000
R1000 SERIES INSULIN PUMP
K993184 · LZG
Animas Corp.
General Hospital · 140d
Cleared Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT...
K993190 · HNO
Surgical Instrument Systems (Sis), Ltd.
Ophthalmic · 140d
Cleared Feb 10, 2000
COPALIS RUBELLA IGM
K993291 · LFX
DiaSorin, Inc.
Microbiology · 132d
Cleared Feb 10, 2000
YEASTEST
K993554 · JXB
Diagnostic Markers, Inc.
Microbiology · 113d
Cleared Feb 10, 2000
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D...
K993861 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 87d
Cleared Feb 10, 2000
ULTRABLATOR ELECTRODE
K993885 · JOS
Linvatec Corp.
General & Plastic Surgery · 86d
Cleared Feb 10, 2000
MEDX INTECAM INTERFACE
K993893 · KPS
Medx, Inc.
Radiology · 86d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE...
K993918 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 84d