11 results
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18ms
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Sources: EU EUDAMED, US FDA
FACEGLOV,ANESTHETIC GAS MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
DRIVE SHAFT FOR RIA 2 520MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·January 11, 2022
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYOLYZER ALPHA (CRYOSURG.EQUIP.)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRIVE SHAFT FOR RIA 2 520MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTO·August 12, 2020
DRIVE SHAFT FOR RIA 2 520MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HTO·December 8, 2020
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 7, 2010
TI AXON(TM) LOCKING SCREW STARDRIVE
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·December 6, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014