13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PD CASTA-H
FDA 510(k)
FDA Class 2
·Dental
DW 273 #1
FDA 510(k)
FDA Class 2
·Dental
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 2, 2022
PS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·April 2, 2013
NEXGEN LEGACY KNEE LPS ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 18, 2011
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·April 15, 2008
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·March 8, 2023
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·February 18, 2025
ATTUNE CR FEM LT SZ 7 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·September 17, 2022
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·July 27, 2022
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013