8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SPOTTEST LACTOPHENOL COTTON BLUE STAIN
FDA 510(k)
FDA Class 1
·Microbiology
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
NIO -INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
PRODIGY SM STAT LNG RT 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code LPH·May 31, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 21, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 20, 2010
PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 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
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017