9 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
DISP FIRSTPASS STR PASSR SELF
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code HWQ·November 12, 2019
ORTHOSS RESORBABLE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Dental
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
FDA 510(k)
FDA Class 2
·Radiology
STERILE BASIC PACK
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK HEALTH CARE·Product code KKX·March 27, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 18, 2011
DORADO PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·March 27, 2008
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026