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
65329–65352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2005
THE EDGE DETECTOR, MODEL 1118
K051921 · IYE
Sun Nuclear Corp.
Radiology · 12d
Cleared Jul 27, 2005
MALIBU SPINAL SYSTEM
K051942 · KWP
Seaspine, Inc.
Orthopedic · 12d
Cleared Jul 26, 2005
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
K050542 · LJS
Marian Medical, Inc.
General Hospital · 146d
Cleared Jul 26, 2005
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823 · LBR
Teco Diagnostics
Chemistry · 117d
Cleared Jul 26, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jul 26, 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jul 26, 2005
PLC SCREW
K051310 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 26, 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · LZA
Hartalega Sdn Bhd
General Hospital · 25d
Cleared Jul 26, 2005
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
K051919 · FED
Usgi Medical
Gastroenterology & Urology · 11d
Cleared Jul 25, 2005
TERRAQUANT MQ2000 LASER THERAPY DEVICE
K043055 · ILY
Escada International, Inc.
Physical Medicine · 262d
Cleared Jul 25, 2005
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · KCT
Miltex, Inc.
General Hospital · 143d
Cleared Jul 25, 2005
3TP WORKSPACE
K050862 · LLZ
3tp, LLC
Radiology · 111d
Cleared Jul 25, 2005
TOX A/B QUICK CHEK
K050891 · LLH
Techlab, Inc.
Microbiology · 108d
Cleared Jul 25, 2005
SAFETY NEEDLE
K051019 · JKA
Sarstedt, Inc.
Chemistry · 94d
Cleared Jul 25, 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667,...
K051194 · LJS
Becton, Dickinson & CO
General Hospital · 76d
Cleared Jul 25, 2005
DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
K051261 · ILY
Dynatronics Corp.
Physical Medicine · 70d
Cleared Jul 25, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K051350 · LON
Dade Behring, Inc.
Microbiology · 62d
Cleared Jul 25, 2005
SENTINEL PLASMAPROTEINS CAL 3X
K051457 · JIX
Sentinel Ch. Srl
Chemistry · 53d
Cleared Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687 · JJY
Roche Diagnostics Corp.
Chemistry · 32d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · FMF
Synthes (Usa)
General Hospital · 28d
Cleared Jul 25, 2005
R2 BREAST IMAGING WORKSTATION
K051743 · LLZ
R2 Technology, Inc.
Radiology · 26d
Cleared Jul 25, 2005
ELEKTA ESARTE FRAME SYSTEM
K051746 · HAW
Elekta Instrument AB
Radiology · 26d
Cleared Jul 25, 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · DQD
3M Company
Cardiovascular · 24d
Cleared Jul 22, 2005
ANEFIN, MODEL 100
K033028 · CBN
Axon Medical
Anesthesiology · 665d