13 results · 22ms · Sources: EU EUDAMED, US FDA

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SELF SEAL STERILIZATION POUCH

FDA 510(k)
FDA Class 2 ·General Hospital

Safco One Tray Impression Trays

FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310230253·Safco One Tray impression trays, #3 medium uppe...

PERFORMATRAK

FDA UDI
Respironics, Inc.·00606959000773·PerformaTrak Mask with Standard Elbow, Small, R...

MODIFICATION TO FLOUROLAB PLUS

FDA 510(k)
FDA Class 2 ·Neurology

L.A.M. IPM WOUND GEL

FDA 510(k)
FDA Unclassified ·Unknown

DAVINCI XI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2023

TRILOGY 200

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·March 21, 2013

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011

FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·April 3, 2008

BIO-MEDICUS NG 27 FR VENOUS CANNULA

FDA Adverse Event
Injury ·PERFUSION SYSTEMS·Product code DWF·November 10, 2023

BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·October 12, 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

The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018