9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
FDA 510(k)
FDA Class 2
·General Hospital
LOTUS VALVE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NPT·April 3, 2025
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·April 10, 2013
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·April 5, 2011
SPECIFY
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code LGW·May 22, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024