17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017958·K-Wire, Double Ended, Trocar Point, Diameter 0....
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017941·K-Wire, Double Ended, Trocar Point, Diameter Si...
SHENGKUN CHEMICAL
FDA 510(k)
FDA Class 1
·General Hospital
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
FDA 510(k)
FDA Class 2
·Cardiovascular
VIDAS® TOXO IGG II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LGD·June 17, 2019
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 25, 2022
EARLYVUE VS30 VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 6, 2008
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·July 27, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 26, 2013
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021
EARLYVUE VS30 VITALS MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021
AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 5, 2026
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022