9 results · 19ms · Sources: EU EUDAMED, US FDA

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REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SORING GMBH SONOCA 180/190

FDA 510(k)
FDA Unclassified ·Unknown

SPARTAN A-10

FDA 510(k)
FDA Class 2 ·Dental

COATED VICRYL (POLYGLACTIN 910) SUTURE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code GAM·April 23, 2013

PAD CONNECTOR CABLE

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·March 31, 2011

DA+ T SERIES SR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DXY·July 10, 2008

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

FDA Enforcement
Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018