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
76201–76224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2002
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K020580 · LPH
Biomet, Inc.
Orthopedic · 29d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · CGA
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Mar 21, 2002
ODI TALON INTRAMEDULLARY HIP NAIL
K014189 · JDS
Orthopedic Designs, Inc.
Orthopedic · 90d
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 21, 2002
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
K014207 · GEI
Aesculap, Inc.
General & Plastic Surgery · 90d
Cleared Mar 21, 2002
SECCA SYSTEM
K014216 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 21, 2002
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
K014248 · KNA
Urogyn , Ltd.
Obstetrics & Gynecology · 85d
Cleared Mar 21, 2002
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
K020001 · INI
Transworld Mobility Distribution, LLC
Physical Medicine · 78d
Cleared Mar 21, 2002
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
K020002 · INI
Transworld Mobility Distribution, LLC
Physical Medicine · 78d
Cleared Mar 21, 2002
SAFYRE SLING SYSTEM
K020007 · OTN
Promedon
Gastroenterology & Urology · 78d
Cleared Mar 21, 2002
OPTILUX 501
K020091 · EBZ
Kerr Corporation (Danbury)
Dental · 70d
Cleared Mar 21, 2002
URS-IG (GLUCOSE TEST)
K020175 · JIL
Teco Diagnostics
Chemistry · 63d
Cleared Mar 21, 2002
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
K020180 · GZJ
Woodside Biomedical, Inc.
Neurology · 62d
Cleared Mar 21, 2002
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET
K020450 · JJY
Maine Standards Co.
Chemistry · 38d
Cleared Mar 21, 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · MQP
Depuyacromed
Orthopedic · 30d
Cleared Mar 21, 2002
ARTHROCARE CONTROLLER
K020557 · GEI
Arthrocare Corp.
General & Plastic Surgery · 29d
Cleared Mar 21, 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558 · GWM
Integra Neurosciences
Neurology · 29d
Cleared Mar 21, 2002
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622
K020635 · MQB
Eastman Kodak Company
Radiology · 22d
Cleared Mar 21, 2002
PVS 1500 SDS
K020733 · KRA
Precision Vascular Systems, Inc.
Cardiovascular · 15d
Cleared Mar 21, 2002
CAT ACTIVE WHEELCHAIR
K020737 · IOR
Movingpeople.Net
Physical Medicine · 15d
Cleared Mar 20, 2002
RESORB-X RESORBABLE PLATING SYSTEM
K011590 · JEY
KLS-Martin L.P.
Dental · 301d
Cleared Mar 20, 2002
PELVICFLEXER EXERCISE DEVICE
K011688 · HIR
Pelvicflex, Inc.
Gastroenterology & Urology · 293d
Cleared Mar 20, 2002
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
K012989 · DQA
Dolphin Medical, Inc.
Anesthesiology · 195d