20 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIETHKE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 17, 2018
ZILVER BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 5, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 26, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 8, 2026
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 16, 2011
SILVERHAWK PLAQUE EXCISION CATHETER SYSTEM
FDA Adverse Event
Injury
·FOX HOLLOW TECHNOLOGIES·Product code MCW·March 26, 2008
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 2, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2020
FGE CATHETER, BILIARY, DIAGNOSTIC
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 13, 2019
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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014