14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIXED BEARING UNI COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120216211·Carbide, LongLife PERIO-PRO
SERIES 7000 STANDARD TIBIA
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·June 14, 2007
DARDIK CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
KOALA CLAMP, KOALA CLAMP AND CUTTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Cannula
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114060400·Sterile Nexframe/Starfix Stainless Steel Guide ...
Cannula
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290014954106·Sterile Nexframe/Starfix Stainless Steel Guide ...
Sterile cannula
FDA UDI
ALPHA OMEGA ENGINEERING CO. LTD.·07290114061568·
NAMIC/VA
FDA Adverse Event
Malfunction
·NAMIC/VA·Product code LJT·May 16, 2008
PROMUS ELEMENT ¿
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013
COOK PNEUMOTHORAX SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DQR·March 10, 2011
INDURA
FDA Adverse Event
Malfunction
·RICE CREEK MFG.·Product code LKK·March 26, 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
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