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
64129–64152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2005
DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
K052340 · IMG
Alfa Tech Medical Systems, Ltd.
Physical Medicine · 105d
Cleared Dec 09, 2005
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
K052396 · CAW
Oxysure Systems, Inc.
Anesthesiology · 100d
Cleared Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539 · FGE
Cook, Inc.
Gastroenterology & Urology · 85d
Cleared Dec 09, 2005
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC...
K052586 · IOR
Taiwan an I Co., Ltd.
Physical Medicine · 80d
Cleared Dec 09, 2005
MEDISIZE GOLD
K052615 · BTT
Medisize BV
Anesthesiology · 77d
Cleared Dec 09, 2005
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
K052622 · EKZ
Macan Engineering Co.
Dental · 77d
Cleared Dec 09, 2005
BREFORMANCE
K052781 · EBG
Bredent-Products For the Dental...
Dental · 67d
Cleared Dec 09, 2005
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
K052804 · DJZ
Omega Point Systems, LLC
Chemistry · 66d
Cleared Dec 09, 2005
I-NEB INSIGHT AAD SYSTEM
K052941 · CAF
Profile Therapeutics Plc
Anesthesiology · 50d
Cleared Dec 09, 2005
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
K053120 · FOZ
Excelsior Medical Corp.
General Hospital · 32d
Cleared Dec 09, 2005
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · LBS
Dade Behring, Inc.
Chemistry · 25d
Cleared Dec 09, 2005
DEXTROSCOPE & DEXTROBEAM
K053162 · LLZ
Volume Interactions Pte, Ltd.
Radiology · 25d
Cleared Dec 09, 2005
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
K053189 · JDC
Zimmer, Inc.
Orthopedic · 24d
Cleared Dec 09, 2005
CURAE'LASE CL1000 IR LASER SYSTEM
K053201 · ILY
Curae'Lase, Inc.
Physical Medicine · 23d
Cleared Dec 09, 2005
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
K053258 · IYN
Hitachi Medical Corp.
Radiology · 17d
Cleared Dec 09, 2005
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL...
K053346 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 7d
Cleared Dec 09, 2005
HOFFMANN II ROD TO WIRE COUPLING
K053349 · KTT
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Dec 08, 2005
ROBIN HOOD VEST
K051300 · FRP
Kamber Corporation
General Hospital · 204d
Cleared Dec 08, 2005
CADIMAS VERSION 1.0
K052023 · LNH
Alan Penn & Associates., Inc.
Radiology · 135d
Cleared Dec 08, 2005
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
K052221 · FRN
Sorenson Medical, Inc.
General Hospital · 115d
Cleared Dec 08, 2005
RESOLUTION ENDOVASCULAR SYSTEM
K052428 · QEY
Omnisonics Medical Technologies
Cardiovascular · 97d
Cleared Dec 08, 2005
MPS ACACIA MEDFLO ELASTOMERIC PUMP
K052451 · MEB
Mps Acacia
General Hospital · 92d
Cleared Dec 08, 2005
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052490 · DZE
Northern Implants, LLC
Dental · 87d
Cleared Dec 08, 2005
MIRA-FLEX 18 MICROCATHETER
K052841 · KRA
Cook, Inc.
Cardiovascular · 62d