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
63673–63696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2006
GRT LITE, MODEL 8-A
K050668 · NHN
Grt Solutions, Inc.
Physical Medicine · 325d
Cleared Feb 03, 2006
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN,...
K051217 · MHX
Ge Healthcare
Cardiovascular · 267d
Cleared Feb 03, 2006
VIELLE LUBRICANT
K051288 · HIS
Cst Medical Limited
Obstetrics & Gynecology · 261d
Cleared Feb 03, 2006
AEGIS ANTERIOR LUMBAR PLATE SYSTEM
K052546 · KWQ
Depuy Spine, Inc.
Orthopedic · 140d
Cleared Feb 03, 2006
HOCA EZ-CARE BP108, TENDER-CARE BP109
K052671 · DXN
Hoca Medical Microsystem, Inc.
Cardiovascular · 129d
Cleared Feb 03, 2006
COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING
K052696 · FRO
Covalon Technologies, Ltd.
General & Plastic Surgery · 128d
Cleared Feb 03, 2006
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
K052796 · GEI
Valleylab
General & Plastic Surgery · 123d
Cleared Feb 03, 2006
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
K053006 · DXQ
Rossmax Internationl , Ltd.
Cardiovascular · 100d
Cleared Feb 03, 2006
INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A
K053204 · CCK
Draeger Medical AG & Co. Kgaa
Anesthesiology · 79d
Cleared Feb 03, 2006
RES TRAXX DATA CENTER
K053205 · BZD
Resmed, Ltd.
Anesthesiology · 79d
Cleared Feb 03, 2006
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
K053240 · CAW
Sunrise Medical
Anesthesiology · 77d
Cleared Feb 03, 2006
CEDARA I-RESPONSE CEDARA PET/CT
K053301 · LLZ
Cedara Software Corp.
Radiology · 67d
Cleared Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
K053371 · OTM
American Medical Systems, Inc.
Gastroenterology & Urology · 60d
Cleared Feb 03, 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · LCP
Microgenics Corp.
Chemistry · 58d
Cleared Feb 03, 2006
EZLOC FEMORAL FIXATION DEVICE
K053461 · MBI
Arthrotek, Inc.
Orthopedic · 52d
Cleared Feb 03, 2006
MAESTRO MDTL LASER SYSTEM
K053473 · ILY
Advanced Medical Technologies, Inc.
Physical Medicine · 51d
Cleared Feb 03, 2006
FRAMELESS RADIOSURGERY COMPONENTS
K053500 · IYE
Brainlab AG
Radiology · 49d
Cleared Feb 03, 2006
IMMULITE/IMMULITE 1000 TURBO INTACT PTH
K053533 · CEW
Diagnostic Products Corporation
Chemistry · 46d
Cleared Feb 03, 2006
TEMPBOND CLEAR WITH TRICLOSAN
K053565 · EMA
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Feb 03, 2006
TENDON WRAP TENDON PROTECTOR
K053655 · FTM
Integra LifeSciences Corporation
General & Plastic Surgery · 35d
Cleared Feb 03, 2006
BIOGRAPH 6
K060060 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 25d
Cleared Feb 03, 2006
STRAUMANN ORTHOSYSTEM
K060062 · OAT
Institut Straumann AG
Dental · 25d
Cleared Feb 03, 2006
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
K060088 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Feb 03, 2006
SUNIPAN IMAGING SYSTEM & ACCESSORIES
K060149 · MUH
Suni Medical Imaging, Inc.
Radiology · 14d