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
74353–74376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · JDI
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 21, 2002
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K022916 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 79d
Cleared Nov 21, 2002
TRX VERTICAL POSITIONER
K023426 · ITI
Motion Concepts
Physical Medicine · 41d
Cleared Nov 21, 2002
WIZAIR COMPRESSION SYSTEM
K023573 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 28d
Cleared Nov 21, 2002
FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
K023585 · FPA
Intravascular Incorporated
General Hospital · 27d
Cleared Nov 21, 2002
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
K023622 · DWF
Stockert Instrumente GmbH
Cardiovascular · 23d
Cleared Nov 21, 2002
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
K023711 · FLL
Acute Ideas Co. , Ltd.
General Hospital · 17d
Cleared Nov 20, 2002
CYNOSURE PHOTOGENICA SV
K021444 · GEX
Cynosure, Inc.
General & Plastic Surgery · 198d
Cleared Nov 20, 2002
QUICKLAB RSV
K021789 · GQG
Integrated Biotechnology Corp.
Microbiology · 173d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779 · HSH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Nov 20, 2002
IMAGECHECKER-CT WORKSTATION
K023003 · LLZ
R2 Technology, Inc.
Radiology · 72d
Cleared Nov 20, 2002
SONOREAL 3D
K023473 · IYO
Bio Medi Com
Radiology · 35d
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · NBW
Bayer Corp.
Chemistry · 26d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ
Nidek, Inc.
Ophthalmic · 377d
Cleared Nov 19, 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 252d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679 · KWP
Ortho Tec, LLC
Orthopedic · 182d
Cleared Nov 19, 2002
ASSUFIL
K021767 · GAM
Assut Europe S.P.A.
General & Plastic Surgery · 174d
Cleared Nov 19, 2002
INSOUND XT SERIES HEARING AID
K021867 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 166d
Cleared Nov 19, 2002
HIP MODULE FOR THE STEALTHSTATION SYSTEM
K021980 · HAW
Medtronic Surgical Navigation...
Neurology · 155d
Cleared Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
K022516 · NBC
Roche Diagnostics Corp.
Chemistry · 112d
Cleared Nov 19, 2002
PHFW-10
K022539 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 110d