20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032613·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl D...
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403032613·26MM X 110MM Tube
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187877·Battalion, LLIF Trial, 15°, 26 mm Wide, 13 mm X...
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
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
2520274-2013-01784
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·April 3, 2013
ETHICON HARMONIC ACE CURVED SHEARS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY·Product code LFL·March 23, 2011
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 22, 2008
STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010
MEN'S LIBERTY
FDA Adverse Event
Injury
·ARGENTUM MEDICAL, LLC·Product code NOA·June 20, 2025
MEN'S LIBERTY
FDA Adverse Event
Injury
·ARGENTUM MEDICAL, LLC·Product code NOA·March 28, 2025
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