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
61465–61488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2006
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
K062421 · MRD
Mentor Corporation
General & Plastic Surgery · 53d
Cleared Oct 10, 2006
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 27d
Cleared Oct 10, 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
K062777 · LTT
Dade Behring, Inc.
Microbiology · 22d
Cleared Oct 10, 2006
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
K062829 · NBW
Tyson Bioresearch, Inc.
Chemistry · 20d
Cleared Oct 06, 2006
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197 · MQG
Minitube of America, Inc.
Obstetrics & Gynecology · 617d
Cleared Oct 06, 2006
ACCESS EPO ASSAY
K052223 · GGT
Beckman Coulter, Inc.
Hematology · 417d
Cleared Oct 06, 2006
SILVERLON CA (CALCIUM ALGINATE)
K053590 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 287d
Cleared Oct 06, 2006
CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES
K060927 · DQY
Ceres Medical Systems, LLC
Cardiovascular · 185d
Cleared Oct 06, 2006
D-STAT DRY HEMOSTATIC BANDAGE
K061219 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 158d
Cleared Oct 06, 2006
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
K061232 · FRO
Acrymed, Inc.
General & Plastic Surgery · 157d
Cleared Oct 06, 2006
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
K061362 · HAW
Plus Orthopedics AG
Neurology · 143d
Cleared Oct 06, 2006
TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
K061614 · ILY
Escada International, Inc.
Physical Medicine · 119d
Cleared Oct 06, 2006
ZERION ALPHA,
K061804 · EIH
Etkon International GmbH
Dental · 101d
Cleared Oct 06, 2006
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
K062054 · LLZ
Eizo Nanao Corporation
Radiology · 78d
Cleared Oct 06, 2006
PASS 2 SPINAL SYSTEM
K062136 · MNI
Medicrea
Orthopedic · 72d
Cleared Oct 06, 2006
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
K062302 · KDQ
Millicore AB
General Hospital · 59d
Cleared Oct 06, 2006
RTVUE
K062552 · OBO
Optovue, Inc.
Ophthalmic · 37d
Cleared Oct 06, 2006
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K062609 · DQY
AngioDynamics, Inc.
Cardiovascular · 31d
Cleared Oct 06, 2006
ORTHOXP
K062634 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Oct 06, 2006
EBI ARAY SPINAL SYSTEM
K062685 · NKB
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 06, 2006
FLEXITOUCH SYSTEM
K062818 · JOW
Tactile Systems Technology, Inc.
Cardiovascular · 16d
Cleared Oct 05, 2006
EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
K061408 · MVM
Euroimmun Us, LLC
Immunology · 136d
Cleared Oct 05, 2006
KMI CEMENT RESTRICTOR IMPLANT
K061465 · JDK
Kinetikos Medical, Inc.
Orthopedic · 132d
Cleared Oct 05, 2006
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
K061575 · CJY
Olympus America, Inc.
Chemistry · 120d