12 results
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28ms
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Sources: EU EUDAMED, US FDA
CODMAN SUCTION PATTIE
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450029305·
LINER: MPACT FLAT PE HC LINER 32/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 30, 2021
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDLINE ELECTRONIC POSITIONING CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
SEALING UNIT FROM 5MM TROCARS
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
REDUCING CONVERTER 10/12MM TO 5MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
LIFESTENT VASCULAR STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·May 28, 2014
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·January 8, 2013
POSTERIOR CHAMBER LENS
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 12, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 10, 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