16 results · 21ms · Sources: EU EUDAMED, 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