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

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176,076 results
71209–71232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2003
DIGITAL AMBULATORY ECG (HOLTER) RECORDER
K031074 · MWJ
Datrix
Cardiovascular · 194d
Cleared Oct 15, 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · KGO
Cardinalhealth
General Hospital · 174d
Cleared Oct 15, 2003
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
K031408 · FYA
Deroyal
General Hospital · 163d
Cleared Oct 15, 2003
SC TOTAL HIP SYSTEM
K031474 · JDI
Orthopedic Alliance, LLC
Orthopedic · 159d
Cleared Oct 15, 2003
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · HAW
Ebi, L.P.
Neurology · 133d
Cleared Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
K032167 · HWC
Mitek Worldwide
Orthopedic · 91d
Cleared Oct 15, 2003
RHYTHM TOUCH Q 2-WAY
K032178 · IPF
Shockim Enterprises, Ltd.
Physical Medicine · 91d
Cleared Oct 15, 2003
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC...
K032223 · GEI
Cook Vascular, Inc.
General & Plastic Surgery · 86d
Cleared Oct 15, 2003
DAMON FT
K032408 · DYW
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Oct 15, 2003
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · MBH
Smith & Nephew, Inc.
Orthopedic · 47d
Cleared Oct 15, 2003
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
K032792 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 37d
Cleared Oct 15, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-250
K032919 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 23d
Cleared Oct 15, 2003
EKG SPEAKS
K032926 · KRE
Medtronic Vascular
Cardiovascular · 23d
Cleared Oct 15, 2003
MODIFICATION TO: HORIZON 9000WS
K032997 · DXG
Mennen Medical , Ltd.
Cardiovascular · 20d
Cleared Oct 15, 2003
MEDELA CLARIO HOME CARE PUMP
K033179 · BTA
Medela AG
General & Plastic Surgery · 14d
Cleared Oct 14, 2003
E-STRIP
K031769 · EGJ
Eemso, Inc.
Physical Medicine · 127d
Cleared Oct 14, 2003
AUTOALIGN
K032186 · LLZ
Cortechs Labs, Inc.
Radiology · 89d
Cleared Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661 · LCX
ACON Laboratories, Inc.
Chemistry · 47d
Cleared Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · MID
Corgenix, Inc.
Immunology · 29d
Cleared Oct 14, 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904 · EIA
Dentsply Intl.
Dental · 27d
Cleared Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · DLJ
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
K033185 · CJE
Roche Diagnostics Corp.
Chemistry · 13d
Cleared Oct 14, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · QEY
Ekos Corp.
Cardiovascular · 11d
Cleared Oct 10, 2003
INSIGHT MILLENNIUM III
K023209 · IKN
Fasstech
Neurology · 379d