19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDLEY PCA MODULE, MODEL 8120
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032233·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm A...
Nihon Kohden Digital Health Solutions, LLC.
FDA registration
Nihon Kohden Digital Health Solutions, LLC.·4 products·🇺🇸 United States
BVI SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRATUS CS TROPONIN I CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2032233-2017-00239
FDA Adverse Event
Malfunction
·June 29, 2018
XORAN
FDA Adverse Event
Malfunction
·XORAN TECHNOLOGIES, INC.·Product code JAK·May 9, 2011
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014
SCP CONTROL PANEL
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022
STOCKERT JMS CENTRIFUGAL PUMP SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
UNKNOWN ZIMMER VIVACIT-E LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·March 29, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011
SYNCHRON LX20
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·April 21, 2008
STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010
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
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