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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
43105–43128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2012
C1-6-D ULTRASOUND TRANSDUCER
K122921 · ITX
Ge Healthcare
Radiology · 11d
Cleared Oct 04, 2012
ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
K120110 · LZA
Profit Point Manufacturing Sdn Bhd
General Hospital · 265d
Cleared Oct 04, 2012
NIRVANA A PERSONAL LUBRICANT
K120706 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 210d
Cleared Oct 04, 2012
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
K121047 · DZE
Kj Meditech Co., Ltd.
Dental · 181d
Cleared Oct 04, 2012
ACTIVE SCREW BONE SCREW
K121682 · HWC
Intelligent Implant Systems, LLC
Orthopedic · 119d
Cleared Oct 04, 2012
Z-MED Z-MED II
K122012 · OZT
NuMED, Inc.
Cardiovascular · 86d
Cleared Oct 04, 2012
MIXJECT WITH SPRAY HEAD
K122023 · FMF
Medimop Medical Projects, Ltd.
General Hospital · 85d
Cleared Oct 04, 2012
STERRAD(R) CYCLESURE(R) 24 BIOLOGICAL INDICATOR
K122044 · FRC
Advanced Sterilization Products
General Hospital · 84d
Cleared Oct 04, 2012
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM
K122231 · DZE
Megagen Implant Co., Ltd.
Dental · 70d
Cleared Oct 04, 2012
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · ODP
Spineart
Orthopedic · 59d
Cleared Oct 04, 2012
MINISPIR
K122384 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 59d
Cleared Oct 03, 2012
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100
K111518 · JOJ
Advanced Sterilization Products
General Hospital · 489d
Cleared Oct 03, 2012
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202
K111519 · JOJ
Advanced Sterilization Products
General Hospital · 489d
Cleared Oct 03, 2012
ORTHOFIX SCREW
K113650 · OAT
Bonafix Surgical and Dental Implants,...
Dental · 296d
Cleared Oct 03, 2012
SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
K120125 · DXQ
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared Oct 03, 2012
NIRVANA B PERSONAL LUBRICANT
K120751 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 205d
Cleared Oct 03, 2012
SMARTBUILDER SYSTEM
K120951 · JEY
Osstem Implant Co., Ltd.
Dental · 187d
Cleared Oct 03, 2012
HT-WEDGE
K121287 · FNG
D.T. Davis Enterprises Ltd. T/A...
General Hospital · 156d
Cleared Oct 03, 2012
EK DELIVERY DEVICE
K121579 · OTZ
Tdak Medical, Inc.
Ophthalmic · 126d
Cleared Oct 03, 2012
AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER
K122009 · IYN
Panasonic Healthcare Co., Ltd.
Radiology · 86d
Cleared Oct 03, 2012
LOGIQ S7 EXPERT, LOGIQ S7 PRO
K122114 · IYN
Ge Healthcare
Radiology · 78d
Cleared Oct 03, 2012
LIGAFIX INTERFERENCE SCREW
K122228 · MAI
Sbm Sciences For Bio Materials
Orthopedic · 69d
Cleared Oct 03, 2012
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
K122450 · IYE
Mitsubishi Heavy Industries, Ltd.
Radiology · 51d
Cleared Oct 03, 2012
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
K122599 · DDR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d