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
68953–68976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2004
SSA-770A, APLIO VERSION 5.5
K041499 · IYN
Toshibamedical Systems Corporation
Radiology · 3d
Cleared Jun 09, 2004
RANDOX AMIKACIN
K033884 · KLQ
Randox Laboratories, Ltd.
Chemistry · 177d
Cleared Jun 09, 2004
MEDICAL AIR COMPRESSOR
K040220 · BTI
eVent Medical, Ltd.
Anesthesiology · 128d
Cleared Jun 09, 2004
MAXO2+, MODEL A AND AE
K040484 · CCL
Maxtec, Inc.
Anesthesiology · 105d
Cleared Jun 09, 2004
RADENT PROPHY PASTE
K040661 · EJR
Pascal Co., Inc.
Dental · 89d
Cleared Jun 09, 2004
MIS DENTAL IMPLANT SYSTEM
K040807 · DZE
Mis - Implant Technologies , Ltd.
Dental · 72d
Cleared Jun 09, 2004
HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER...
K041035 · BZD
Hoffrichter GmbH
Anesthesiology · 49d
Cleared Jun 09, 2004
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
K041156 · DQA
Nonin Medical, Inc.
Anesthesiology · 37d
Cleared Jun 09, 2004
HOUVA 3 PHOTOTHERAPY SYSTEM
K041212 · FTC
National Biological Corp.
General & Plastic Surgery · 30d
Cleared Jun 09, 2004
EG-3630UR
K041395 · ITX
Pentax Precision Instrument Corp.
Radiology · 14d
Cleared Jun 09, 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K041396 · ITX
Pentax Precision Instrument Corp.
Radiology · 14d
Cleared Jun 09, 2004
EG-3830UT
K041397 · ITX
Pentax Precision Instrument Corp.
Radiology · 14d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 8d
Cleared Jun 08, 2004
MICRODERM, MODEL/VERSION 3.5
K040171 · PSN
Visiomed AG
General & Plastic Surgery · 134d
Cleared Jun 08, 2004
MRA-CMS
K040746 · LLZ
Medis Medical Imaging Systems BV
Radiology · 77d
Cleared Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813 · CEW
Nichols Institute Diagnostics
Chemistry · 70d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
bioMerieux, Inc.
Microbiology · 68d
Cleared Jun 08, 2004
POISE DATAENGINE
K040969 · MWI
Poise Technology Corporation
Cardiovascular · 55d
Cleared Jun 08, 2004
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K041041 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 47d
Cleared Jun 08, 2004
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
K041146 · IPF
Control Solutions, Inc.
Physical Medicine · 36d
Cleared Jun 08, 2004
IPACS ORTHO
K041366 · LLZ
Realtimeimage, Inc.
Radiology · 15d
Cleared Jun 08, 2004
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
K041380 · OEB
R2 Technology, Inc.
Radiology · 14d
Cleared Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · LCX
Unipath , Ltd.
Chemistry · 13d
Cleared Jun 07, 2004
VPAP III ST-A
K033276 · MNS
Resmed, Ltd.
Anesthesiology · 241d