16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Instru-Safe Instrument Protection System
FDA 510(k)
FDA Class 2
·General Hospital
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741426300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674142630060·
KELMAN-McPHERSON TISSUE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896073531·KELMAN-McPHERSON TISSUE FORCEPS LONG ANGLED TIP
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·July 29, 2013
IN:C2 SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REVLIGHT SKIN CARE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·September 23, 2014
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·October 6, 2014
UNKNOWN_INSTRUMENTS_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·June 3, 2013
TOTALCARE-
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 21, 2011
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018
PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014