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

Filters: Cleared only ×
175,820 results
100009–100032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
K955264 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
HEARING AID IMPRESSION MATERIAL
K955288 · ESD
Crown Delta Corp.
Ear, Nose, Throat · 78d
Cleared Feb 02, 1996
FINETONE FSC,
K955692 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 50d
Cleared Feb 02, 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · DQX
Terumo Medical Corp.
Cardiovascular · 42d
Cleared Feb 02, 1996
RESOUND PERSONAL HEARING SYSTEM BT247
K955867 · ESD
Resound Corp.
Ear, Nose, Throat · 36d
Cleared Feb 01, 1996
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
K950481 · JIA
Isolab, Inc.
Chemistry · 363d
Cleared Feb 01, 1996
DEPUY VISION AML HIP PROTHESIS
K953694 · LPH
Depuy, Inc.
Orthopedic · 177d
Cleared Feb 01, 1996
DEPUY VISION SOLUTION HIP PROSTHESIS
K953703 · LPH
Depuy, Inc.
Orthopedic · 177d
Cleared Feb 01, 1996
HANAULUX BLUE 30 & 80
K954169 · FSY
Heraeus Med GmbH
General & Plastic Surgery · 149d
Cleared Feb 01, 1996
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
K954714 · DTB
Pacesetter, Inc.
Cardiovascular · 122d
Cleared Feb 01, 1996
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
K954848 · MAL
Meadox Medicals, Div. Boston...
Cardiovascular · 101d
Cleared Feb 01, 1996
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K955364 · OXD
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 71d
Cleared Feb 01, 1996
OTV-S5 OES VIDEO SYSTEM
K955404 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 66d
Cleared Feb 01, 1996
RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
K955683 · MJG
Contour Fabricators of Florida, Inc.
General & Plastic Surgery · 49d
Cleared Feb 01, 1996
VALLEYLAB COATED ELECTRODES
K955836 · GEI
Valleylab, Inc.
General & Plastic Surgery · 37d
Cleared Jan 31, 1996
MARS DIGITAL BLOOD PRESSURE MONITOR
K945215 · DXN
Mars Metal Co., Ltd.
Cardiovascular · 463d
Cleared Jan 31, 1996
RESPIRONICS MONARCH MINI MASK
K945938 · BZD
Respironics, Inc.
Anesthesiology · 422d
Cleared Jan 31, 1996
MODEL 7355
K952491 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 246d
Cleared Jan 31, 1996
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
K952859 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 223d
Cleared Jan 31, 1996
ULTIMA SIZE 0 CEMENTED FEMORAL STEM
K953200 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 205d
Cleared Jan 31, 1996
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
K953202 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 205d
Cleared Jan 31, 1996
MITEK THREADED ANCHOR (FASTIN)
K953560 · MBI
Mitek Surgical Products, Inc.
Orthopedic · 195d
Cleared Jan 31, 1996
PRODEK
K953609 · GAW
Sutures , Ltd.
General & Plastic Surgery · 182d
Cleared Jan 31, 1996
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
K953925 · LZO
Biomet, Inc.
Orthopedic · 166d