11 results
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28ms
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Sources: EU EUDAMED, US FDA
IRSG I-MOVER FOR BEDS
FDA 510(k)
FDA Class 2
·General Hospital
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING
FDA 510(k)
FDA Class 2
·Anesthesiology
IMP,TSV,4.1MM,SBM,13
FDA Adverse Event
Injury
·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 19, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 25, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·October 21, 2025
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 18, 2024
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·November 1, 2023
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