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
63817–63840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2006
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
K053321 · FTA
Xodus Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jan 19, 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K053350 · JXG
Codman & Shurtleff, Inc.
Neurology · 48d
Cleared Jan 19, 2006
CAUTERY TIP CLEANER, MODEL 30500
K053433 · GEI
Xodus Medical, Inc.
General & Plastic Surgery · 41d
Cleared Jan 19, 2006
SPECIMEN RETRIEVAL SYSTEM
K060051 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 13d
Cleared Jan 18, 2006
CRITIVIEW
K051145 · DPW
Critisense , Ltd.
Cardiovascular · 259d
Cleared Jan 18, 2006
OPTILENE MESH LP
K053158 · FTL
Aesculap, Inc.
General & Plastic Surgery · 65d
Cleared Jan 18, 2006
SIROLASER
K053161 · GEX
Sirona Dental Systems GmbH
General & Plastic Surgery · 65d
Cleared Jan 18, 2006
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
K053259 · LYZ
Practical Protective Plastic...
General Hospital · 57d
Cleared Jan 18, 2006
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
K053380 · NEW
Surgical Specialties Corp
General & Plastic Surgery · 44d
Cleared Jan 18, 2006
GLASS CERAMICS
K053438 · EIH
3M Espe AG Dental Products
Dental · 40d
Cleared Jan 18, 2006
3160 MRI PATIENT MONITORING SYSTEM
K053462 · MWI
Invivo Corporation
Cardiovascular · 36d
Cleared Jan 18, 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · HBC
Aesculap, Inc.
Neurology · 30d
Cleared Jan 18, 2006
EXCELART VANTAGE ZGV
K060003 · LNH
Toshibamedical Systems Corporation
Radiology · 15d
Cleared Jan 17, 2006
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566 · FLL
Proton Healthcare , Ltd.
General Hospital · 217d
Cleared Jan 17, 2006
SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF
K052485 · NWZ
Midi, Inc.
Microbiology · 130d
Cleared Jan 17, 2006
SUPER SHEATH INTRODUCER SHEATH
K052557 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 123d
Cleared Jan 17, 2006
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
K052570 · DWF
Cardiacassist, Inc.
Cardiovascular · 120d
Cleared Jan 17, 2006
SUTURING WASHER
K052642 · MAB
First Call, Inc.
Cardiovascular · 113d
Cleared Jan 17, 2006
RM3 RENAL PRESERVATION SYSTEM
K053169 · KDK
Waters Instruments, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 17, 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · NBW
Lifescan, Inc.
Chemistry · 29d
Cleared Jan 17, 2006
COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
K053634 · MQB
Agfa Corporation
Radiology · 19d
Cleared Jan 13, 2006
DBX STRIP
K042829 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 458d
Cleared Jan 13, 2006
KAPP BARI-RING, MODEL KS-BR-2005
K050384 · NEU
Kapp Surgical Instrument, Inc.
General & Plastic Surgery · 332d
Cleared Jan 13, 2006
CARDIOSOFT PC ECG, USB VERSION
K052295 · DPS
Cardiosoft, L.P.
Cardiovascular · 143d