Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76801–76824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2002
JOE LUBE CONDOM
K011363 · HIS
Marketing Sales Concepts, Inc. (Msci)
Obstetrics & Gynecology · 326d
Cleared Mar 25, 2002
JOE LUB HELMET CONDOM
K011378 · HIS
Marketing Sales Concepts, Inc. (Msci)
Obstetrics & Gynecology · 326d
Cleared Mar 25, 2002
ZOLL PAD
K011388 · MKJ
Zoll Medical Corp
Cardiovascular · 322d
Cleared Mar 25, 2002
UNICEM
K020256 · EMA
3M Espe AG Dental Products
Dental · 60d
Cleared Mar 25, 2002
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN
K020870 · LON
bioMerieux, Inc.
Microbiology · 87d
Cleared Mar 23, 2002
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
K020596 · JIT
Diamond Diagnostics, Inc.
Chemistry · 29d
Cleared Mar 22, 2002
PRONTO
K014240 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037 · JWY
Dade Microscan, Inc.
Microbiology · 77d
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