16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESSURE ACTIVATED CHECK VALVE
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450211038·
UNICORN MODEL SYS0630
FDA 510(k)
FDA Class 2
·Radiology
SIDEPORT PINCH CLAMP DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·December 8, 2006
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 13, 2012
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·Product code KWP·November 2, 2021
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 9, 2011
UNKNOWN_OSTEOSYNTHESIS_PRODUCT
FDA Adverse Event
Injury
·STRYKER TRAUMA SELZACH·Product code HRS·August 15, 2014
TECNIS ACRYLIC
FDA Adverse Event
Injury
·ADVANCED MEDICAL OPTICS·Product code HQL·March 11, 2008
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 21, 2013
BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·January 22, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020