10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFIED VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307351·Diamond, torpedo conical, medium grit
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
SPEEDYBELL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·March 26, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·April 17, 2008
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