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
62065–62088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2006
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · EJL
B.T.I. Biotechnology Institute, Sl.
Dental · 77d
Cleared Aug 03, 2006
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE
K061492 · FMF
Tyco Healthcare
General Hospital · 64d
Cleared Aug 03, 2006
AVS ASL PEEK SPACER SYSTEM
K061836 · MQP
Stryker Spine
Orthopedic · 35d
Cleared Aug 03, 2006
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50
K061986 · LJS
Medcomp
General Hospital · 21d
Cleared Aug 03, 2006
TRIATHLON LOW PROFILE TIBIAL TRAY
K062037 · JWH
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Aug 02, 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
K050842 · FRO
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 488d
Cleared Aug 02, 2006
MED SCULPT
K053041 · IMI
General Project S.R.L.
Physical Medicine · 279d
Cleared Aug 02, 2006
PEPER
K060297 · DXH
Medical Monitors, Ltd.
Cardiovascular · 177d
Cleared Aug 02, 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226 · LPH
Zimmer, Inc.
Orthopedic · 92d
Cleared Aug 02, 2006
SMARTMONITOR 2PS
K061256 · NPF
Respironics, Inc.
Anesthesiology · 90d
Cleared Aug 02, 2006
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K061344 · JDI
Aesculap, Inc.
Orthopedic · 79d
Cleared Aug 02, 2006
LANGSTON DUAL LUMEN CATHETER
K061565 · DQO
Vascular Solutions, Inc.
Cardiovascular · 58d
Cleared Aug 02, 2006
VISION VXC CENTRAL STATION, MODEL 4300
K061675 · MHX
Invivo Corporation
Cardiovascular · 49d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · JIX
Dade Behring, Inc.
Chemistry · 47d
Cleared Aug 02, 2006
BLOXX RAPID CLOTTING AGENT
K061722 · QSY
Crosslink-D, Inc.
General & Plastic Surgery · 44d
Cleared Aug 02, 2006
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3
K061822 · DXN
Omron Healthcare, Inc.
Cardiovascular · 35d
Cleared Aug 02, 2006
U-CLIP DEVICE, MODEL NC65
K062057 · FZP
Medtronic Vascular
General & Plastic Surgery · 13d
Cleared Aug 01, 2006
MEDCOMP VASCU-SHEATH II
K053092 · DYB
Medcomp
Cardiovascular · 271d
Cleared Aug 01, 2006
12SL ECG ANALYSIS PROGRAM
K060833 · MHX
Ge Medical Systems Information...
Cardiovascular · 127d
Cleared Aug 01, 2006
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
K061373 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Aug 01, 2006
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
K061392 · JOY
Ikonisys, Inc.
Hematology · 74d
Cleared Aug 01, 2006
DORNIER MEDILAS H 20 LASER
K061455 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 68d
Cleared Aug 01, 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K061486 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 62d
Cleared Aug 01, 2006
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 61d