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

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175,820 results
49201–49224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2010
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102124 · MUH
VATECH Co., Ltd.
Radiology · 85d
Cleared Oct 22, 2010
VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
K102135 · MWI
Nuvon, Inc.
General Hospital · 85d
Cleared Oct 22, 2010
SENSEI X ROBOTIC CATHETER SYSTEM
K102168 · DXX
Hansen Medical, Inc.
Cardiovascular · 81d
Cleared Oct 22, 2010
BLO2X OXYGEN BLOCKER
K102526 · EBF
Pascal Co., Inc.
Dental · 50d
Cleared Oct 22, 2010
Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
K102680 · KPR
Control-X Medical, Inc.
Radiology · 35d
Cleared Oct 22, 2010
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K102991 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared CT Oct 22, 2010
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
K103095 · LOX
Medtronic, Ireland
Cardiovascular · 14d
Cleared Oct 21, 2010
CHARMCARE TABLETOP PULSE OXIMETER
K092641 · DQA
Charmcare Co., Ltd.
Anesthesiology · 420d
Cleared Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · LON
bioMerieux, Inc.
Microbiology · 386d
Cleared Oct 21, 2010
TOKUYAMA SHIELD FORCE
K100172 · LBH
Tokuyama Dental Corporation
Dental · 273d
Cleared Oct 21, 2010
EXACTECH GPS
K100742 · OLO
Blue Ortho
Orthopedic · 219d
Cleared Oct 21, 2010
WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS
K100960 · MUH
Cefla Dental Group
Radiology · 197d
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Oct 21, 2010
WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
K101006 · GEX
Alcon Research, Ltd.
General & Plastic Surgery · 192d
Cleared Oct 21, 2010
BOND BONE
K101014 · LYC
Mis Implants Technologies , Ltd.
Dental · 192d
Cleared Oct 21, 2010
REMIN PRO
K101104 · EJR
Voco GmbH
Dental · 184d
Cleared Oct 21, 2010
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
K101145 · FMK
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 181d
Cleared Oct 21, 2010
URGENT PC STIMULATOR
K101847 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 112d
Cleared Oct 21, 2010
MASIMO LNCS/M-LNCS OXIMETRY SENSORS
K101896 · DQA
Masimo Corporation
Anesthesiology · 106d
Cleared Oct 21, 2010
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM
K102262 · MBI
Arthrocare Corp.
Orthopedic · 72d
Cleared Oct 21, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102559 · LYZ
Tangshan Hengda Plastic Products Co.,...
General Hospital · 44d
Cleared Oct 21, 2010
INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40,...
K102562 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 44d
Cleared Oct 21, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102569 · LYZ
Tangshan Kangyuan Glove Co., Ltd.
General Hospital · 44d
Cleared Oct 21, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K102570 · LYZ
Tangshan Kangjie Glove Co., Ltd.
General Hospital · 44d