17 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEXIVA CLOSED IV CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032843·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs A...
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
FDA 510(k)
FDA Class 2
·Dental
PORTADUR P 2, MODEL #2031
FDA 510(k)
FDA Class 2
·Dental
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016
AMINGO
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 3, 2013
UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 29, 2011
52X26 ACETABULAR INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWB·April 22, 2008
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 4, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 4, 2024
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024