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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
41713–41736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2013
PASS OCT SPINAL SYSTEM
K121979 · KWP
Medicrea International
Orthopedic · 258d
Cleared Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · CEW
Siemens Healthcare Diagnostics
Chemistry · 258d
Cleared Mar 21, 2013
CLEVER TD-7001NEBULIZER
K122060 · CAF
Taidoc Technology Corporation
Anesthesiology · 251d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · DXN
Andon Health Co, Ltd.
Cardiovascular · 248d
Cleared Mar 21, 2013
GARAVENTA X3 INCLINED PLATFORM LIFT
K122206 · PCE
Garaventa (Canada) Ltd [Dba Garaventa...
Physical Medicine · 239d
Cleared Mar 21, 2013
ADVANCE TOTAL KNEE SYSTEM-PATELLA
K122218 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 239d
Cleared Mar 21, 2013
SUNRAY FETAL MONITOR
K123335 · HGM
Sunray Medical Apparatus Co., Ltd.
Obstetrics & Gynecology · 146d
Cleared Mar 21, 2013
BP652N (HEM-6300-Z)
K123498 · DXN
Omron Healthcare, Inc.
Cardiovascular · 128d
Cleared Mar 21, 2013
S9 VPAP TX
K123511 · MNS
Resmed, Ltd.
Anesthesiology · 128d
Cleared Mar 21, 2013
CAPNO MODULE, 92517
K130112 · CCK
Spacelabs Healthcare
Anesthesiology · 64d
Cleared Mar 21, 2013
HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
K130221 · DZE
Medimecca Co., Ltd.
Dental · 51d
Cleared Mar 21, 2013
DORNIER MEDILAS UROPULSE
K130344 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 38d
Cleared Mar 21, 2013
PINPOINTE FOOTLASER
K130413 · GEX
Nuvolase, Inc.
General & Plastic Surgery · 30d
Cleared Mar 21, 2013
VEEDA 100% COTTON MENSTRUAL TAMPON
K130609 · HEB
Naturalena Brands, Inc.
Obstetrics & Gynecology · 14d
Cleared Mar 21, 2013
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
K130619 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Mar 20, 2013
INTERVENTIONAL HEMOSTATIC BANDAGE
K120782 · QSY
Z-Medica Corporation
General & Plastic Surgery · 370d
Cleared Mar 20, 2013
BD ALCOHOL SWAB
K121655 · LKB
Becton, Dickinson & CO
General Hospital · 288d
Cleared Mar 20, 2013
VANGUARD XP KNEE SYSTEM
K122160 · MBH
Biomet Manufacturing Corp
Orthopedic · 243d
Cleared Mar 20, 2013
LIDCORAPID V2 MONITOR
K122247 · DXG
Lidco, Ltd.
Cardiovascular · 236d
Cleared Mar 20, 2013
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
K123403 · HRS
Stryker Trauma AG
Orthopedic · 135d
Cleared Mar 20, 2013
DEMI ULTRA
K123468 · EBZ
Kerr Corporation
Dental · 131d
Cleared Mar 20, 2013
TX1 TISSUE REMOVAL SYSTEM
K123640 · LFL
Tenex Health
General & Plastic Surgery · 114d
Cleared Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
K123687 · JWH
Exactech, Inc.
Orthopedic · 107d
Cleared Mar 20, 2013
E-Z CHEK BLOOD LEAK TEST STRIPS
K123805 · FJD
Reprocessing Products Corp
Gastroenterology & Urology · 99d