14 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ONEVIEW INTERFACE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TruLock
FDA UDI
Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036024819·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450148440·
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935100126·
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 455GE PHASED ARRAY WRIST COIL
FDA 510(k)
FDA Class 2
·Radiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 8, 2013
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·May 7, 2008
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 5, 2011
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·August 22, 2018
3.0 RIO® ROBOTIC ARM - MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·September 18, 2019
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018