12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLLAGEN SPONGE
FDA 510(k)
FDA Unclassified
·Unknown
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR30928051·Molar retainers (100 pcs.)
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 21, 2021
KENDRO HERACELL CO2 INCUBATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AUTOMARQER
FDA 510(k)
FDA Class 2
·Hematology
DIDECO COMPACTFLO EVOLUTION OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 5, 2011
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 3, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·August 20, 2014
ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·March 3, 2026
BD 25G Spinal Needles. (Spinal Anesthesia Needle)
FDA Recall
Terminated
·Becton Dickinson & Company·Product code BSP·March 16, 2005
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